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Inmunoglobulina intravenosa para el tratamiento de la enfermedad de Kawasaki en niños

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References

Referencias de los estudios incluidos en esta revisión

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excluded studies
additional references

Barron KS, Murphy DJ Jr, Silverman ED, Ruttenberg HD, Wright GB, Franklin W, et al. Treatment of Kawasaki syndrome: a comparison of two dosage regimens of intravenously administered immune globulin. Journal of Pediatrics 1990;117(4):638-44.

Harada K. Intravenous gamma-globulin treatment in Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):805-10.

Okuni M, Harada K, Yamaguchi H, Yanagawa H, Sonobe T, Kawasaki T. Intravenous gamma globulin therapy in Kawasaki disease; trial of low dose gamma globulin. Progress in Clinical and Biological Research 1987;250:433-9.

Okuni M, Harada K. Intravenous gamma globulin therapy in Kawasaki disease; Kawasaki Disease Research Committee study. Progress in Medicine 1987;7:83-7.

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Harada K. Intravenous gamma-globulin treatment in Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):805-10.

Okuni M, Harada K, Yamaguchi H, Yanagawa H, Sonobe T, Kawasaki T. Intravenous gamma globulin therapy in Kawasaki disease; trial of low dose gamma globulin. Progress in Clinical and Biological Research 1987;250:433-9.

Okuni M, Harada K. Intravenous gamma globulin therapy in Kawasaki disease; Kawasaki Disease Research Committee study. Progress in Medicine. Progress in Medicine 1987;7:83-7.

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Harada K. Intravenous gamma-globulin treatment in Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):805-10.

Okuni M, Harada K, Yamaguchi H, Yanagawa H, Sonobe T, Kawasaki T. Intravenous gamma globulin therapy in Kawasaki disease; trial of low dose gamma globulin. Progress in Clinical and Biological Research 1987;250:433-9.

Okuni M, Harada K. Intravenous gamma globulin therapy in Kawasaki disease; Kawasaki Disease Research Committee study. Progress in Medicine 1987;7:83-7.

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Harada K. Intravenous gamma-globulin treatment in Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):805-10.

Okuni M, Harada K, Yamaguchi H, Yanagawa H, Sonobe T, Kawasaki T. Intravenous gamma globulin therapy in Kawasaki disease; trial of low dose gamma globulin. Progress in Clinical and Biological Research 1987;250:433-9.

Harada K. Intravenous gamma-globulin treatment in Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):805-10.

Okuni M, Harada K, Yamaguchi H, Yanagawa H, Sonobe T, Kawasaki T. Intravenous gamma globulin therapy in Kawasaki disease; trial of low dose gamma globulin. Progress in Clinical and Biological Research 1987;250:433-9.

Harada K. Intravenous gamma-globulin treatment in Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):805-10.

Okuni M, Harada K, Yamaguchi H, Yanagawa H, Sonobe T, Kawasaki T. Intravenous gamma globulin therapy in Kawasaki disease; trial of low dose gamma globulin. Progress in Clinical and Biological Research 1991;250:433-9.

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Harada K, Yamaguchi H. Intravenous gamma globulin treatment in Kawasaki disease; comparison between high dose and low dose. Progress in Medicine 1989;9:45-8.

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Harada K. Intravenous gamma-globulin treatment in Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):805-10.

Morikawa Y, Ohashi Y, Harada K, Asai T, Okawa S, Nagashima M, et al. A multicenter, randomized, controlled trial of intravenous gamma globulin therapy in children with acute Kawasaki disease. Acta Paediatrica Japonica 1994;36(4):347-54.

Morikawa Y, Ohashi Y, Harada K, Asai T, Okawa S, Nagashima M, et al. A multicenter, randomized, controlled trial of intravenous gamma globulin therapy in children with acute Kawasaki disease. Acta Paediatrica Japonica 1994;36(4):347-54.

Morikawa Y, Ohashi Y, Harada K, Asai T, Okawa S, Nagashima M, et al. A multicenter, randomized, controlled trial of intravenous gamma globulin therapy in children with acute Kawasaki disease. Acta Paediatrica Japonica 1994;36(4):347-54.

Nagashima M, Matsushima M, Matsuoka H, Ogawa A, Okumura N. High dose gammaglobulin therapy for Kawasaki disease. Journal of Pediatrics 1987;110(5):710-2.

Glode MP, Joffe S, Wiggins J Jr, Clarke SH, Hathaway WE. Effect of intravenous immune globulin on the coagulopathy of Kawasaki syndrome. Journal of Pediatrics 1989;115(3):469-73.

Newburger JW, Sanders SP, Burns JC, Parness IA, Beiser AS, et al. Left ventricular contractility and function in Kawasaki syndrome; effect of intravenous gamma-globulin. Circulation 1989;79(6):1237-46.

Newburger JW, Takahashi M, Burns JC, Beiser AS, Chung KJ, Duffy CE, et al. The treatment of Kawasaki syndome with intravenous gamma globulin. New England Journal of Medicine 1986;315(6):341-7.

Takahashi M, Newburger JW. Long-term follow-up of coronary abnormalities in Kawasaki syndrome treated with and without IV gamma globulin. Circulation 1990;82:717.

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Newburger J. Preliminary results of the multicenter trial on IVGG treatment of Kawasaki disease with single vs. four-infusion regime. Pediatric Research 1990;27:22A.

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Newburger JW, Takahashi M, Beiser AS, Burns JC, Bastian J, Chung KJ, et al. A single intravenous infusion of gamma globulin as compared with four infusions in the treatment of acute Kawasaki syndrome. New England Journal of Medicine 1991;324(23):1633-9.

Nishihara S, Ishibashi K, Iribe K, Matsuda I. Intravenous gammaglobulin and reduction of coronary artery abnormalities in children with Kawasaki Disease. Lancet 1988;2(8617):973.

Nishihara S, Ishibashi K, Iribe K, Matsuda I. Intravenous gammaglobulin and reduction of coronary artery abnormalities in children with Kawasaki Disease. Lancet 1988;2(8617):973.

Nishihara S, Ishibashi K, Iribe K, Matsuda I. Intravenous gammaglobulin and reduction of coronary artery abnormalities in children with Kawasaki Disease. Lancet 1988;2(8617):973.

Ogino H, Ogawa M, Harima Y, Kono S, Ohkuni H, Nishida M, et al. Clinical evaluation of gammaglobulin preparations for the treatment of Kawasaki disease. Progress in Clinical and Biological Research 1987;250:555-6.

Ogino H, Ogawa M, Harima Y, Kono S, Ohkuni H, Nishida M, et al. High-dose intravenous gammaglobulin treatment of Kawaski disease. Progress in Medicine 1990;10:29-38.

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Ogino H, Ogawa M, Harima Y, Kono S, Ohkuni H, Nisida M, et al. Clinical evaluation of gamma globulin preparations for the treatment of Kawasaki disease - trial of 200mg/kg/day. Journal of the Japanese Pediatric Society 1987;91(12):2849-56.

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Ogawa M, Ogino H, Harima Y, Kono S, Ohkuni H, Nishida M, et al. High dose gamma globulin therapy for Kawasaki disease. Journal of the Japanese Pediatric Society 1997;91(12):3763-71.

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Ogino H, Ogawa M, Harima Y, Kono S, Ohkuni H, Nishida M, et al. Clinical evaluation of gammaglobulin preparations for the treatment of Kawasaki disease. Progress in Clinical and Biological Research 1987;250:555-6.

Ogino H, Ogawa M, Harima Y, Kono S, Ohkuni H, Nishida M, et al. High-dose intravenous gammaglobulin treatment of Kawaski disease. Progress in Medicine 1990;10:29-38.

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Ogino H, Ogawa M, Harima Y, Kono S, Ohkuni H, Nishida M, et al. High-dose intravenous gammaglobulin treatment of Kawaski disease. Progress in Medicine 1990;10:29-38.

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Yabiku M, Kojima S, Ogawa M, Ogino H, Harima Y, Kono S, Ohkuni H, et al. High dose gammaglobulin therapy for Kawasaki disease. Journal of the Japanese Pediatric Society 1989;93(12):2721-31.

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Onouchi Z, Isogai Y, Yanagisawa M, Yamanouchi T, Matsuda H, Morita T, et al. Multicenter randomized controlled study of intravenous immunoglobulin in Kawasaki disease. Journal of the Japanese Pediatric Society 1988;92(11):2367-76.

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Onouchi Z, Yanagisawa M, Hirayama T, Kiyosawa N, Matsuda H, Nakashima M. Optimal dosage and differences in therapeutic efficacy of IGIV in Kawasaki disease. Acta Paediatrica Japonica 1995;37(1):40-6.

Onouchi Z, Yanagisawa M, Shiraishi H, Hirayama T, Katsube Y, Kiyosawa N, et al. Multicenter randomized controlled study of intravenous immunoglobulin G (C-425). Journal of the Japanese Pediatric Society 1992;96(12):2669-79.

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Onouchi Z, Isogai Y, Yanagisawa M, Yamanouchi T, Matsuda H, Morita T, et al. Multicenter randomized controlled study of intravenous immunoglobulin in Kawasaki disease. Journal of the Japanese Pediatric Society 1988;92(11):2367-76.

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Onouchi Z, Yanagisawa M, Hirayama T, Kiyosawa N, Matsuda H, Nakashima M. Optimal dosage and differences in therapeutic efficacy of IGIV in Kawasaki disease. Acta Paediatrica Japonica 1995;37(1):40-6.

Onouchi Z, Yanagisawa M, Shiraishi H, Hirayama T, Katsube Y, Kiyosawa N, et al. Multicenter randomized controlled study of intravenous immunoglobulin G (C-425). Journal of the Japanese Pediatric Society 1992;96(12):2669-79.

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Onouchi Z, Isogai Y, Yanagisawa M, Yamanouchi T, Matsuda H, Morita T, et al. Multicenter randomized controlled study of intravenous immunoglobulin in Kawasaki disease. Journal of the Japanese Pediatric Society 1988;92(11):2367-76.

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Onouchi Z, Yanagisawa M, Hirayama T, Kiyosawa N, Matsuda H, Nakashima M. Optimal dosage and differences in therapeutic efficacy of IGIV in Kawasaki disease. Acta Paediatrica Japonica 1995;37(1):40-6.

Onouchi Z, Yanagisawa M, Shiraishi H, Hirayama T, Katsube Y, Kiyosawa N, et al. Multicenter randomized controlled study of intravenous immunoglobulin G (C-425). Journal of the Japanese Pediatric Society 1992;96(12):2669-79.

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Onouchi Z, Yanagisawa M, Hirayama T, Kiyosawa N, Matsuda H, Nakashima M. Optimal dosage and differences in therapeutic efficacy of IGIV in Kawasaki disease. Acta Paediatrica Japonica 1995;37(1):40-6.

Onouchi Z, Yanagisawa M, Shiraishi H, Hirayama T, Katsube Y, Kiyosawa N, et al. Multicenter randomized controlled study of intravenous immunoglobulin G (C-425). Journal of the Japanese Pediatric Society 1992;96(12):2669-79.

Google Scholar

Onouchi Z, Yanagisawa M, Hirayama T, Kiyosawa N, Matsuda H, Nakashima M. Optimal dosage and differences in therapeutic efficacy of IGIV in Kawasaki disease. Acta Paediatrica Japonica 1995;37(1):40-6.

Onouchi Z, Yanagisawa M, Shiraishi H, Hirayama T, Katsube Y, Kiyosawa N, et al. Multicenter randomized controlled study of intravenous immunoglobulin G (C-425). Journal of the Japanese Pediatric Society 1992;96(12):2669-79.

Google Scholar

Onouchi Z, Yanagisawa M, Hirayama T, Kiyosawa N, Matsuda H, Nakashima M. Optimal dosage and differences in therapeutic efficacy of IGIV in Kawasaki disease. Acta Paediatrica Japonica 1995;37(1):40-6.

Onouchi Z, Yanagisawa M, Shiraishi H, Hirayama T, Katsube Y, Kiyosawa N, et al. Multicenter randomized controlled study of intravenous immunoglobulin G (C-425). Journal of the Japanese Pediatric Society 1992;96(12):2669-79.

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Sato N, Sugimura T, Akagi T, Inoue O, Ono E, Kato H. Selective gammaglobulin treatment in Kawasaki disease: single 2 g/kg or 400 mg/kg/day for 5 days? In: Kato H, editors(s). Kawasaki Disease. Amsterdam: Elsevier Science, 1995:332-8.

Sato N, Sugimura T, Akagi T, Yamakawa R, Hashino K, Eto G, et al. Selective high dose gamma-globulin treatment in Kawasaki disease: assessment of clinical aspects and cost effectiveness. Pediatrics International 1999;41(1):1-7.

Referencias de los estudios excluidos de esta revisión

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included studies
additional references

Brogan PA, Bose A, Burgner D, Shingadia D, Tulloh R, Michie C, et al. Kawasaki disease: an evidence based approach to diagnosis, treatment, and proposals for future research. Archives of Disease in Children 2002;86(4):286-90.

Burns J, Glode M, Capparelli E, Brown J, Newburger J. Intravenous gammaglobulin treatment in Kawasaki syndrome: are all brands equal? In: Kato H, editors(s). Kawasaki Disease. Amsterdam: Elsevier Science, 1995:296-300.

Dunning DW, Hussey ME, Riggs T, Bestervelt R, Goerke C. Long-term follow-up with stress echocardiograms of patients with Kawasaki's disease. Cardiology 2002;97(1):43-8.

Engle MA, Fatica NS, Bussel JB, O'Loughlin JE, Snyder MS, Lesser ML. Clinical trial of single-dose intravenous gamma globulin in acute Kawasaki disease. Preliminary report. American Journal of Disease in Childhood 1989;143(11):1300-4.

Fasth A, Andersson J, Elinder G. Intravenous administration of immunoglobulin speeds up improvement in Kawasaki disease [Intravenöst givet immunglobulin ger snabb bättring vid Kawasakis sjukdom]. Lakartidningen 1990;87(50):4315-7.

Fournier A, van Doesburg NH, Guerin R, Lapointe N, Lacroix J, Fouron JC et al. Kawasaki's disease. Epidemiological aspects and cardiovascular manifestations. A propos of 106 cases [La maladie de Kawasaki. Aspects épidémiologiques et manisfestation cardio-vasculaires. A propos de 106 observations]. Archives des Maladies du Coeur et des Vaisseaux 1985;78(5):693-8.

Fukunishi M, Kikkawa M, Hamana K, Onodera T, Matsuzaki K, Matsumoto Y, et al. Prediction of non-responsiveness to intravenous high-dose gamma-globulin therapy in patients with Kawasaki disease at onset. Journal of Pediatrics 2000;137(2):172-6.

Fukushige J, Takahashi N, Ueda K, Okada K, Miyazaki C, Maeda Y. Kawasaki disease and human parvovirus B19 antibody: role of immunoglobulin therapy. Acta Paediatrica Japonica 1995;37(6):758-60.

Furusho K, Sato K, Soeda T, Matsumoto H, Okabe T, Hirota T, et al. High-dose intravenous gammaglobulin for Kawasaki disease. Lancet 1983;2(8363):1359.

Furusho K, Kamiya T, Nakano H, Kiyosawa N, Shinomiya K, Hayashidera T, et al. High-dose intravenous gammaglobulin for Kawasaki disease. Lancet 1984;2(8411):1055-8.

Furusho K, Kamiya T, Nakano H, Kiyosawa N, Shinomiya K, Hayashidera T, et al. Intravenous gamma-globulin for Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):799-804.

Furusho K, Kamiya T, Nakano H, Kiyosawa N, Shinomiya K, Hayashidera T, et al. Intravenous gamma-globulin for Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):799-804.

Furusho K, Kamiya T, Nakano H, Kiyosawa N, Shinomiya K, Hayashidera T, et al. Intravenous gamma-globulin for Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):799-804.

Furusho K, Kamiya T, Nakano H, Kiyosawa N, Shinomiya K, Hayashidera T, et al. Intravenous gamma-globulin for Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):799-804.

Furusho K, Kamiya T, Nakano H, Kiyosawa N, Shinomiya K, Hayashidera T, et al. Intravenous gamma-globulin for Kawasaki disease. Acta Paediatrica Japonica 1991;33(6):799-804.

Harada K, Yamaguchi H, Kato H, Nishibayashi Y, Seki I, Okazaki T, et al. Indications for intravenous gammaglobulin treatment for Kawasaki disease. In: Procedings of the 4th international symposium of Kawasaki disease. 1991:459-62.

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Newburger JW, Sanders SP, Burns JC, Parness IA, Beiser AS, Colan SD. Left ventricular contractility and function in Kawasaki syndrome. Effect of intravenous gamma-globulin. Circulation 1989;79(6):1237-46.

Newburger JW. Treatment of Kawasaki disease. Lancet 1996;347(9009):1128.

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Pallotto E, Shulman S, Rowley A, Goldberg C. Does treatment of Kawasaki disease within the first 7 days of illness improve the long-term outcome compared to later (8-10th day) treatment? In: Kato H, editors(s). Kawasaki disease. Amsterdam: Elsevier Science, 1995:305-9.

Plotkin S, Daum R, Giebink G, Hall C, Lepow M, Marcuse E, et al. American Academy of Pediatrics, Committee on Infectious Diseases: Intravenous gamma-globulin use in children with Kawasaki disease. Pediatrics 1988;82(1):122.

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Saalouke MG, Venglarcik JS 3rd, Baker DR, Saalouke ZI, Bashour TT. Rapid regression of coronary dilatation in Kawasaki disease with intravenous gamma-globulin. American Heart Journal 1991;121(3 Pt 1):905-9.

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Referencias adicionales

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included studies
excluded studies

Centers for Disease Control, New York. Kawasaki Disease. MMWR 1980;29:61.

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Link to article

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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excluded studies

Barron 1990

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: randomised schedule in blocks of 4 and assigned in sequential order Timing of randomisation: at diagnosis Blinding: yes (single ‐ outcome assessors) Power calculation: nil Number of centres: 7 51 patients randomised 7 exclusions 44 patients analysed Source of funding: partly funded by Baxter Healthcare Corporation
Participants	Children with fever for at least 3 consecutive days and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see Description of Studies in the main body of the review). Chldren who were not within the first 7 days of onset of symptoms were excluded from the study Age: 30.1 +/‐ 19.1 in the 400 mg/kg/day group, 38.2 +/‐ 22.2 in the 1gm/kg group Location: US and Canada Timing and duration: 1987‐1988
Interventions	400mg/kg/day of purified human IVIG + 80 to 100 mg/kg/day oral aspirin until 25 hours after resolution of fever, than 3 to 5 mg/kg for a minimum of 2 months VS 1 gm/kg of purified human IVIG + 80 to100 mg/kg/day oral aspirin until 25 hours after resolution of fever, than 3 to 5 mg/kg for a minimum of 2 months Duration: 4 days (400mg/kg/day), single dose (1 gm/kg)
Outcomes	Coronary artery aneurysms Adverse effects Duration of fever
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Harada 1991A(1)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised randomisation Timing of randomisation: at diagnosis Blinding: unclear Power calculation: nil Number of centres: not stated. However the paper states "multicentre" 214 patients randomised in all 3 comparisons 1 exclusion 213 patients analysed Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Diagnostic criteria not stated Age: under 4 years Location: Japan Timing and duration: 1983‐1985
Interventions	100 mg/kg/day pepsin‐treated IVIG + 50 mg/kg/day oral aspirin VS 100 mg/kg/day intact‐type IVIG + 50 mg/kg/day oral aspirin Duration: Single dose
Outcomes	Coronary artery abnormalities
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Harada 1991A(2)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised randomisation Timing of randomisation: at diagnosis Blinding: unclear Power calculation: nil Number of centres: not stated. However the paper states "multicentre" 214 patients randomised in all 3 comparisons 1 exclusion 213 patients analysed Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Diagnostic criteria not stated Age: under 4 years Location: Japan Timing and duration: 1983‐1985
Interventions	100 mg/kg/day pepsin‐treated IVIG + 50 mg/kg/day oral aspirin Control: 50 mg/kg/day oral aspirin Duration: Single dose (IVIG), aspirin duration not stated
Outcomes	Coronary artery abnormalities
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Harada 1991A(3)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised randomisation Timing of randomisation: at diagnosis Blinding: unclear Power calculation: nil Number of centres: not stated. However the paper states "multicentre" 214 patients randomised in all 3 comparisons 1 exclusion 213 patients analysed Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Diagnostic criteria not stated Age: under 4 years Location: Japan Timing and duration: 1983‐1985
Interventions	100 mg/kg/day intact‐type IVIG + 50 mg/kg/day oral aspirin Control: 50 mg/kg/day oral aspirin Duration: Single dose (IVIG), aspirin duration not stated
Outcomes	Coronay artery abnormalities
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Harada 1991B(1)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised randomisation Timing of randomisation: at diagnosis Blinding: unclear Power calculation: nil Number of centres: not stated. However the paper states "multicentre" 295 patients randomised in all 3 comparisons 6 exclusions at 30 days, 17 at 60 days and 18 at 1 year 289 patients analysed at 30 days, 278 at 60 days and 277 at one year Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Diagnostic criteria not stated Age: under 4 years Location: Japan Timing and duration: 1985‐1986
Interventions	100 mg/kg/day pepsin‐treated IVIG + 50 mg/kg/day oral aspirin VS 100 mg/kg/day intact‐type IVIG + 50 mg/kg/day oral aspirin Duration: 5 days
Outcomes	Coronary artery abnormalities
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Harada 1991B(2)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised randomisation Timing of randomisation: at diagnosis Blinding: unclear Power calculation: nil Number of centres: not stated. However the paper states "multicentre" 295 patients randomised in all 3 comparisons 6 exclusions at 30 days, 17 at 60 days and 18 at 1 year 289 patients analysed at 30 days, 278 at 60 days and 277 at a year Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Diagnostic criteria not stated Age: under 4 years Location: Japan Timing and duration: 1985‐1986
Interventions	100 mg/kg/day pepsin‐treated IVIG + 50 mg/kg/day oral aspirin Control: 50 mg/kg/day oral aspirin Duration: 5 days (IVIG), aspirin duration not stated
Outcomes	Coronay artery abnormalities
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Harada 1991B(3)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised randomisation Timing of randomisation: at diagnosis Blinding: unclear Power calculation: nil Number of centres: not stated. However the paper states "multicentre" 295 patients randomised in all 3 comparisons 6 exclusions at 30 days, 17 at 60 days and 18 at 1 year 289 patients analysed at 30 days, 278 at 60 days and 277 at a year Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Diagnostic criteria not stated Age: under 4 years Location: Japan Timing and duration: 1985‐1986
Interventions	100 mg/kg/day intact‐type IVIG + 50 mg/kg/day oral aspirin Control: 50 mg/kg/day oral aspirin Duration: 5 days (IVIG), aspirin duration not stated
Outcomes	Coronary artery abnormalities
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Harada 1991C

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised randomisation Timing of randomisation: at diagnosis Blinding: unclear Power calculation: nil Number of centres: not stated. However the paper states "multicentre" 242 patients randomised 8 exclusions 234 patients analysed Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Diagnostic criteria not stated Age: under 4 years Location: Japan Timing and duration: 1987‐1988
Interventions	100 mg/kg/day intact‐type IVIG + 50 mg/kg/day oral aspirin VS 400 mg/kg/day intact‐type IVIG + 50 mg/kg/day oral aspirin Duration: 5 days
Outcomes	Coronary artery abnormalities
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Morikawa 1994(1)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised Timing of randomisation: time of diagnosis Blinding: yes (triple) Power calculation: yes (80% with 150 in each group) Number of centres: 95 313 patients randomised 2 exclusions from the adverse effects analysis, 11 from the CAA analysis and 11 from the duration of fever analysis 311 patients analysed for the adverse effects outcome, 299 patients analysed for the CAA outcome and 299 patients were analysed for the fever duration outcome Source of funding: not stated
Participants	Children within 9 days from the onset of symptoms and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review) Age: less than 6 years old Location: Japan Timing and duration: 1991‐1993
Interventions	200 mg/kg/day of polyethyleneglycol‐treated human immunoglobulin VS 400 mg/kg/day of IV polyethyleneglycol‐treated human immunoglobulin Duration: 5 days
Outcomes	Coronary artery abnormalities Adverse effects Duration of fever
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Morikawa 1994(2)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised Timing of randomisation: time of diagnosis Blinding: yes (triple) Power calculation: yes (80% with 150 in each group) Number of centres: 95 311 patients randomised 1 exclusion from the adverse effects analysis, 11 from the CAA analysis and 10 from the duration of fever analysis 310 patients analysed for the adverse effects outcome, 299 patients analysed for the CAA outcome and 300 patients were analysed for the fever duration outcome Source of funding: not stated
Participants	Children within 9 days from the onset of symptoms and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review) Age: less than 6 years old Location: Japan Timing and duration: 1991‐1993
Interventions	200 mg/kg/day of polyethyleneglycol‐treated human immunoglobulin VS 200 mg/kg per day of freeze‐dried, sulfonated human immunoglobulin Duration: 5 days
Outcomes	Coronary artery abnormalities Adverse effects Duration of fever
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Morikawa 1994(3)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centralised Timing of randomisation: time of diagnosis Blinding: yes (triple) Power calculation: yes (80% with 150 in each group) Number of centres: 95 312 patients randomised 1 exclusion from the adverse effects analysis, 7 from the CAA analysis and 6 from the duration of fever analysis 311 patients analysed for the adverse effects outcome, 304 patients analysed for the CAA outcome and 305 patients analysed for the fever duration outcome Source of funding: not stated
Participants	Children within 9 days from the onset of symptoms and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review) Age: less than 6 years old Location: Japan Timing and duration: 1991‐1993
Interventions	400 mg/kg/day of IV polyethyleneglycol‐treated human immunoglobulin VS 200 mg/kg per day of freeze‐dried, sulfonated human immunoglobulin Duration: 5 days
Outcomes	Coronary artery abnormalities Adverse effects Duration of fever
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Nagashima 1987

*Study characteristics*
Methods	Unit of randomisation: coronary artery abnormalities Method of randomisation: Random number table Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 16 136 patients randomised 0 exclusions 136 patients analysed Source of funding:
Participants	Chidren within 10 days from onset of symptoms. Diagnostic criteria not stated. Children with coronary artery abnormalities on presentation were excluded Age: 25.6 +/‐ 20.1 months in the IVIG group; 22.7 +/‐ 14.4 months in the aspirin group Location: Japan Timing and duration: 1984‐1986
Interventions	400 mg/kg/day of polyethyleneglycol‐treated IVIG immunoglobulin + 30/mg/kg aspirin Placebo: yes (aspirin only) Duration: 3 days (IVIG), aspirin duration not stated
Outcomes	Coronary artery abnormalities Adverse effects Length of febrile period
Notes	This study has been excluded from the meta‐analysis as it reports total number of coronary artery abnormalities, rather than coronary artery abnormalities per child.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Newburger 1986

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: opaque, sealed, consecutively numbered envelopes Timing of randomisation: at diagnosis Blinding: yes (single ‐ outcome assessors) Power calculation: nil Number of centres: 6 168 patients randomised 4 exclusions 153 patients analysed at 2 weeks, 158 at 7 weeks Source of funding: National Institute of Health
Participants	Children within 10 days from the onset of symptoms and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review) Age: 2.7 +/‐ 0.2 in the IVIG group, 2.3 +/‐ 0.2 in the aspirin only group Location: USA Timing and duration: 1984‐1985
Interventions	400 mg/kg/day intact‐type IVIG + 100mg/kg/day of oral aspirin for 14 days and 3 to 5 mg/kg/day there after Control: 100 mg/kg/day of oral aspirin for 14 days and 3 to 5 mg/kg/day there after Duration: 4 days (IVIG), aspirin duration not given
Outcomes	Coronary atery abnomalities Duration of fever Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Newburger 1991

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: opaque, sealed, consecutively numbered envelopes Timing of randomisation: at diagnosis Blinding: yes (single, outcome assessors) Power calculation: yes (80% power with 350 patients enrolled) Number of centres: 7 549 patients randomised 26 exclusions at 2 weeks, 29 at 7 weeks 523 patients analysed at 2 weeks, 520 at 7 weeks Source of funding: National Institute of Health
Participants	Children within 10 days from the onset of symptoms and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review) Age: 2.9 +/‐ 0.1 in the 400 mg/kg/day group and 2.9 +/‐ 0.1 in the 2 gm/kg single infusion group Location: USA Timing and duration: 1986 to 1989
Interventions	400 mg/kg/day intact‐type IVIG VS 2 gm/kg intact‐type IVIG Duration: 4 days (400 mg/kg/day), single dose (2 gm/kg)
Outcomes	Coronary artery abnormalities Duration of fever Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Nishihara 1988(1)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central randomisation Timing of randomisation: at diagnosis Blinding: yes (single ‐ outcome assessors) Power calculation: nil Number of centres: 13 128 patients randomised 18 exclusions 110 patients analysed Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. diagnostc criteria was not stated. Children were excluded if they had received IVIG prior to randomisation Age: Under 4 years Location: Japan Timing and duration: 1984‐1988
Interventions	50 to100 mg/kg/day of either S‐sulphonated human IVIG or polyethylene‐glycol‐treated IVIG + 30 mg/kg/day oral aspirin VS 200 mg/kg/day of either S‐sulphonated human IVIG or polyethylene‐glycol‐treated IVIG + 30 mg/kg/day oral aspirin Duration: 5 days (IVIG), aspirin duration not stated
Outcomes	Coronary artery dilation
Notes	This trial used historical controls so this group are not included in the review
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Nishihara 1988(2)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central randomisation Timing of randomisation: at diagnosis Blinding: yes (single ‐ outcome assessors) Power calculation: nil Number of centres: 13 128 patients randomised 18 exclusions 110 patients analysed Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. diagnostc criteria were not stated. Children were excluded if they had received IVIG prior to randomisation Age: Under 4 years Location: Japan Timing and duration: 1984‐1988
Interventions	50 to 100 mg/kg/day of either S‐sulphonated human IVIG or polyethylene‐glycol‐treated IVIG + 30 mg/kg/day oral aspirin VS 400 mg/kg/day of either S‐sulphonated human IVIG or polyethylene‐glycol‐treated IVIG + 30 mg/kg/day oral aspirin Duration: 5 days (IVIG), aspirin duration not stated
Outcomes	Coronary artery dilation
Notes	This trial used historical controls so this group are not included in the review
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Nishihara 1988(3)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central randomisation Timing of randomisation: at diagnosis Blinding: yes (single ‐ outcome assessors) Power calculation: nil Number of centres: 13 128 patients randomised 18 exclusions 110 patients analysed Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. diagnostc criteria was not stated. Children were excluded if they had received IVIG prior to randomisation Age: Under 4 years Location: Japan Timing and duration: 1984‐1988
Interventions	200 mg/kg/day of either S‐sulphonated human IVIG or polyethylene‐glycol‐treated IVIG + 30 mg/kg/day oral aspirin VS 400 mg/kg/day of either S‐sulphonated human IVIG or polyethylene‐glycol‐treated IVIG + 30 mg/kg/day oral aspirin Duration: 5 days (IVIG), aspirin duration not stated
Outcomes	Coronary artery dilation
Notes	This trial used historical controls so this group are not included in the review
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Ogino 1987A

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centrally randomised Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 32 115 patients randomised 15 exclusions 96 patients analysed Source of funding: not stated
Participants	Children within 7 days of onset of illness. Diagnostic criteria were not defined. Children who had received any IVIG prior to randomisation were excluded Age: not stated. Until at least 72 months Location: Japan Timing and duration: 1984‐1985
Interventions	200mg/kg/day of S‐Sulphonated IVIG + 30/mg/kg/day of aspirin until serum CPR became negative and then 10/mg/kg/day Control: yes (aspirin only) Duration: 3 days (IVIG), aspirin duration not stated
Outcomes	Coronary artery aneurysms Coronary artery dilations
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Ogino 1987B

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centrally randomised Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 32 142 patients randomised 25 exclusions 117 patients analysed Source of funding: not stated
Participants	Children within 7 days of onset of illness. Diagnostic criteria were not defined. Children who had received any IVIG prior to randomisation were excluded Age: not stated. Untl at least 72 months Location: Japan Timing and duration: 1985‐1986
Interventions	400mg/kg/day of S‐Sulphonated IVIG + 30/mg/kg/day of aspirin until serum CPR became negative and then 10/mg/kg/day Control: yes (aspirin only) Duration: 3 days (IVIG), aspirin duration not stated
Outcomes	Coronary artery aneurysms Coronary artery dilations
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Ogino 1990

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: centrally randomised Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 32 84 patients randomised 0 exclusions 84 patients analysed Source of funding: not stated
Participants	Children within 7 days of onset of illness. Diagnostic criteria were not defined. Children who had received any IVIG prior to randomisation were excluded Age: not stated. Until at least 72 months Location: Japan Timing and duration: 1986‐1988
Interventions	1000mg/kg/day of S‐Sulphonated IVIG + 30/mg/kg/day of aspirin until serum CPR became negative and then 10/mg/kg/day Control: yes (aspirin only) Duration: single dose (IVIG), aspirin duration not stated
Outcomes	Coronary artery aneurysms Coronary artery dilations
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Onouchi 1995A(1)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central radomisation Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 28 148 patients randomised to all 3 comparisons 22 exclusions from all 3 comparisons 126 patients analysed in all comparisons. Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Kawasaki disease diagnosed by the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review). Children who had received steroids, indomethacin or IVIG prior to randomisation were excluded from the study Age: under 5 years Location: Japan Timing and duration: 1986 to 1987
Interventions	200 mg/kg/day of reduced alkylated human IVIG + 50mg/kg/day of aspirin until the patient became afebrile and then 30/mg/kg/day VS 400 mg/kg/day of reduced alkylated human IVIG + 50mg/kg/day of aspirin until the patient became afebrile and then 30/mg/kg/day Duration: 3 days (IVIG), duration of aspirin unclear
Outcomes	Coronary artery anormalities Duration of fever Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Onouchi 1995A(2)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central radomisation Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 28 148 patients randomised to all 3 comparisons 22 exclusions from all 3 comparisons 126 patients analysed in all comparisons. Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Kawasaki disease diagnosed by the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review). Children who had received steroids, indomethacin or IVIG prior to randomisation were excluded from the study Age: under 5 years Location: Japan Timing and duration: 1986 to 1987
Interventions	200 mg/kg/day of reduced alkylated human IVIG + 50mg/kg/day of aspirin until the patient became afebrile and then 30/mg/kg/day Control: yes (aspirin alone) Duration: 3 days (IVIG), duration of aspirin unclear
Outcomes	Coronary artery anormalities Duration of fever Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Onouchi 1995A(3)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central radomisation Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 28 148 patients randomised to all 3 comparisons 22 exclusions from all 3 comparisons 126 patients analysed in all comparisons. Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Kawasaki disease diagnosed by the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review). Children who had received steroids, indomethacin or IVIG prior to randomisation were excluded from the study Age: under 5 years Location: Japan Timing and duration: 1986 to 1987
Interventions	400 mg/kg/day of reduced alkylated human IVIG + 50mg/kg/day of aspirin until the patient became afebrile and then 30/mg/kg/day Control: yes (aspirin alone) Duration: 3 days (IVIG), duration of aspirin unclear
Outcomes	Coronary artery anormalities Duration of fever Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Onouchi 1995B(1)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central radomisation Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 39 169 patients randomised to all 3 comparisons 9 exclusions from all 3 comparisons 160 patients analysed for a coronary artery abnormalities in all 3 comparisons. Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Kawasaki disease diagnosed by the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review) Children who had received steroids, indomethacin or IVIG prior to randomisation were excluded from the study Age: under 5 years Location: Japan Timing and duration: 1990 to 1991
Interventions	100 mg/kg/day pH4 stabilised acid human immmunoglobulin + 30 mg/kg/day of oral aspirin VS 200 mg/kg/day pH4 stabilised acid human immmunoglobulin + 30 mg/kg/day of oral aspirin Duration: 5 days
Outcomes	Coronary artery anormalities Duration of fever Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Onouchi 1995B(2)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central radomisation Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 39 169 patients randomised to all 3 comparisons 9 exclusions from all 3 comparisons 160 patients analysed in all comparisons for coronary artery otcomes. Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Kawasaki disease diagnosed by criteria stipulated by the JKDRC (see the description of studies in the body of the review). Children who had received steroids, indomethacin or IVIG prior to randomisation were excluded from the study Age: under 5 years Location: Japan Timing and duration: 1990 to 1991
Interventions	100 mg/kg/day pH4 stabilised acid human immmunoglobulin + 30 mg/kg/day of oral aspirin VS 400 mg/kg/day pH4 stabilised acid human immmunoglobulin + 30 mg/kg/day of oral aspirin Duration: 5 days
Outcomes	Coronary artery anormalities Duration of fever Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Onouchi 1995B(3)

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: central radomisation Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 39 169 patients randomised to all 3 comparisons 9 exclusions from all 3 comparisons 160 patients analysed in all comparisons for coronary atery outcomes. Source of funding: not stated
Participants	Children within 7 days of the onset of symptoms. Kawasaki disease diagnosed by the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see the description of studies in the body of the review). Children who had received steroids, indomethacin or IVIG prior to randomisation were excluded from the study Age: under 5 years Location: Japan Timing and duration: 1990 to 1991
Interventions	200 mg/kg/day pH4 stabilised acid human immmunoglobulin + 30 mg/kg/day of oral aspirin VS 400 mg/kg/day pH4 stabilised acid human immmunoglobulin + 30 mg/kg/day of oral aspirin Duration: 5 days
Outcomes	Coronary artery anormalities Duration of fever Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ Adequate

Sato 1995

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: random number table Timing of randomisation: at diagnosis Blinding: unclear Power calculation: nil Number of centres: not stated 108 patients randomised 0 exclusions 108 patients analysed Source of funding: not stated
Participants	Children diagnosed with Kawasaki disease (diagnostic criteria not given) and scoring at least four on the Harada scale within the first 9 days of illness (see Description of Studies in the main body of the review). Age: not stated Location: Japan Timing and duration: not stated
Interventions	400 mg/kg/day of IVIG (type not stated) + 30 mg/kg/day of oral aspirin during the febrile period and 5 mg/kg/day there after VS 2 gm/kg IVIG (type not stated) + 30 mg/kg/day of oral aspirin during the febrile period and 5 mg/kg/day there after Duration: 5 days ‐ 400 mg/kg/day, 2 gm/kg ‐ single dose
Outcomes	Coronary artery abnormalities Duration of fever Duration of hospital stay Adverse effects
Notes	Controls in this study were not randomised so are not included in the review.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Sato 1999

*Study characteristics*
Methods	Unit of randomisation: child Method of randomisation: random number table Timing of randomisation: at diagnosis Blinding: not stated. Clearly the patients and the treatment providers were not blinded. It is not stated if outcome assessors had any blinding Power calculation: nil Number of centres: 1 145 patients randomised 0 exclusions 145 patients analysed Source of funding: not stated
Participants	Children with fever for at least 5 consecutive days and meeting the diagnostic criteria for Kawasaki disease as set by the CDC, New York (see Description of Studies in the main body of the review). Children also had to score at least four on the Harada scale within the first 9 days of illness (see Description of Studies in the ain body of the review). Children with coronary artery abnormalities at diagnosis were excluded from the study Age: not stated Location: Japan Timing and duration: 1991‐1995
Interventions	400 mg/kg/day IVIG (type not stated) + 30 mg/kg/day of oral aspirin during the febrile period and 5 mg/kg/day there after VS 2gm/kg IVIG (type not stated) + 30 mg/kg/day of oral aspirin during the febrile period and 5 mg/kg/day there after Duration: 400 mg/kg ‐ 5 days, 2gm/kg ‐single dose
Outcomes	Coronary artery abnormalities Fever duration Duration of hospital stay Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ Unclear

Characteristics of excluded studies [ordered by study ID]

Jump to:

included studies

Study	Reason for exclusion
Brogan 2002	Not an RCT
Burns 1995	Not an RCT
Dunning 2002	Not an RCT
Engle 1989	Not an RCT
Fasth 1990	Not an RCT
Fournier 1985	Not an RCT
Fukunishi 2000	Not an RCT
Fukushige 1995	Not an RCT
Furusho 1983	Not an RCT.
Furusho 1991A	Every effort has been made to contact the authors of this study to confirm randomisation. We have had no reply. If we receive a reply in the future we will reassess the trials eligibility for inclusion
Furusho 1991B(1)	Every effort has been made to contact the authors of this study to confirm randomisation. We have had no reply. If we receive a reply in the future we will reassess the trial's eligibility for inclusion
Furusho 1991B(2)	Every effort has been made to contact the authors of this study to confirm randomisation. We have had no reply. If we receive a reply in the future we will reassess the trial's eligibility for inclusion
Furusho 1991B(3)	Every effort has been made to contact the authors of this study to confirm randomisation. We have had no reply. If we receive a reply in the future we will reassess the trial's eligibility for inclusion
Furusho 1991C	Every effort has been made to contact the authors of this study to confirm randomisation. We have had no reply. If we receive a reply in the future we will reassess the trial's eligibility for inclusion
Harada 1991	Not an RCT
Hsu 1993	Not an RCT
Hwang 1989	Not an RCT
Hwang 1996	Not an RCT
Kondo 1983	Not an RCT
Lux 1991	Not an RCT
Marasini 1991	Not an RCT
Matsushima 1986	Only quasi‐randomisation was used (alternation)
Mori 2000	Not an RCT
Newburger 1989	Not an RCT
Newburger 1996	Not an RCT
Nigrovic 2002	Not an RCT
Nonaka 1995	Drug comparison was IV prednisilone versus IVIG reather IVIG versus placebo or no treatment
Pallotto 1995	Not an RCT
Plotkin 1988	Not an RCT
Rowley 1992	Not an RCT
Saalouke 1991	Not an RCT
Sargraves 1993	Not an RCT
Shimei 1996	Not an RCT
Shinohara 1996	Not an RCT
Siegel 1988	Not an RCT
Silverman 1995	Not an RCT
Suez 1995	Not an RCT
Suzuki 1989	Not an RCT
Terai 1997	Not an RCT
Tse 2002	Not an RCT
Wu 1993	Not an RCT
Yangawa 1999	Not an RCT
Yavez 1996	Not an RCT

Data and analyses

Open in table viewer

Comparison 1. IVIG vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 CAAs. All total doses. All Children. Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1: IVIG vs control, Outcome 1: CAAs. All total doses. All Children.
1.1.1 0 to 30 days	10	970	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.61, 0.90]
1.1.2 31 to 60 days	10	1020	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.51, 1.10]
1.1.3 180+ days	6	721	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.28, 1.17]
1.2 CAAs. All total doses. Excluding children with CAAs at diagnosis Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.2 Comparison 1: IVIG vs control, Outcome 2: CAAs. All total doses. Excluding children with CAAs at diagnosis
1.2.1 0‐30 days	6	521	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.46, 1.00]
1.2.2 31‐60 days	7	527	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.24, 1.04]
1.3 CAAs. All total doses. Only children with CAAs at diagnosis. Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.3 Comparison 1: IVIG vs control, Outcome 3: CAAs. All total doses. Only children with CAAs at diagnosis.
1.3.1 0‐30 days	4	445	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.43, 1.28]
1.3.2 31‐60 days	4	446	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.20, 1.73]
1.4 CAAs. All total doses. All children. Studies using recognised diagnostic criteria. Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.4 Comparison 1: IVIG vs control, Outcome 4: CAAs. All total doses. All children. Studies using recognised diagnostic criteria.
1.4.1 0‐30 days	3	238	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.41, 0.93]
1.4.2 31‐60 days	3	263	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.16, 4.03]
1.5 CAAs. All total doses. No CAAs at enrollment. Studies using recognised diagnostic criteria. Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.5 Comparison 1: IVIG vs control, Outcome 5: CAAs. All total doses. No CAAs at enrollment. Studies using recognised diagnostic criteria.
1.5.1 0‐30 days	3	233	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.43, 0.93]
1.5.2 31‐60 days	3	237	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.14, 1.98]
1.6 CAAs. 100 mg/kg total dose. All children Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.6 Comparison 1: IVIG vs control, Outcome 6: CAAs. 100 mg/kg total dose. All children
1.6.1 0‐30 days	2	213	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.83, 1.31]
1.6.2 31‐60 days	2	213	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.59, 2.22]
1.6.3 180 days+	2	276	Risk Ratio (M‐H, Random, 95% CI)	1.31 [0.35, 4.92]
1.7 CAAs. 500 mg/kg total dose. All children Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.7 Comparison 1: IVIG vs control, Outcome 7: CAAs. 500 mg/kg total dose. All children
1.7.1 0‐30 days	2	283	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.63, 0.84]
1.7.2 31‐60 days	2	276	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.32, 1.01]
1.7.3 180+ days	2	277	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.18, 1.07]
1.8 CAAs. 600 mg/kg total dose. All children Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.8 Comparison 1: IVIG vs control, Outcome 8: CAAs. 600 mg/kg total dose. All children
1.8.1 0‐30 days	2	140	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.67, 1.20]
1.8.2 31‐60 days	2	141	Risk Ratio (M‐H, Random, 95% CI)	1.38 [0.59, 3.18]
1.9 CAAs. 1200 mg/kg total dose. All children Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.9 Comparison 1: IVIG vs control, Outcome 9: CAAs. 1200 mg/kg total dose. All children
1.9.1 0‐30 days	2	175	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.29, 0.92]
1.9.2 31‐60 days	2	175	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.25, 1.71]
1.10 Duration of fever Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.10 Comparison 1: IVIG vs control, Outcome 10: Duration of fever
1.10.1 Duration of fever after initiation of treatment	3	262	Mean Difference (IV, Random, 95% CI)	0.66 [‐4.99, 6.31]

Open in table viewer

Comparison 2. Comparison of dose regimens

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 100 mg/kg x 5 days vs 200 mg/kg x 5 days Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.1 Comparison 2: Comparison of dose regimens, Outcome 1: 100 mg/kg x 5 days vs 200 mg/kg x 5 days
2.1.1 All coronary artery abnormalities ‐ 0‐30 days	2	162	Risk Ratio (M‐H, Random, 95% CI)	1.76 [1.07, 2.89]
2.2 100 mg/kg x 5 days vs 400 mg/kg x 5 days Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.2 Comparison 2: Comparison of dose regimens, Outcome 2: 100 mg/kg x 5 days vs 400 mg/kg x 5 days
2.2.1 All coronary artery abnormalities ‐ 0‐30 days	3	401	Risk Ratio (M‐H, Random, 95% CI)	2.79 [1.59, 4.91]
2.2.2 All coronary artery abnormalities ‐ 31‐60 days	2	333	Risk Ratio (M‐H, Random, 95% CI)	3.14 [1.38, 7.15]
2.3 200 mg/kg x 5 days vs 400 mg/kg x 5 days Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.3 Comparison 2: Comparison of dose regimens, Outcome 3: 200 mg/kg x 5 days vs 400 mg/kg x 5 days
2.3.1 All coronary artery abnormalities ‐ 0‐30 days	4	623	Risk Ratio (M‐H, Random, 95% CI)	2.44 [1.49, 4.00]
2.4 400 mg/kg x 5 days vs 2 gm/kg single dose Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.4 Comparison 2: Comparison of dose regimens, Outcome 4: 400 mg/kg x 5 days vs 2 gm/kg single dose
2.4.1 All coronary artery abnormalities ‐ 0‐30 days	2	253	Risk Ratio (M‐H, Random, 95% CI)	4.47 [1.55, 12.86]
2.5 Fever 200 mg/kg x 3 days vs 400 mg/kg/day x 3 days Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.5 Comparison 2: Comparison of dose regimens, Outcome 5: Fever 200 mg/kg x 3 days vs 400 mg/kg/day x 3 days

Open in table viewer

Comparison 3. Type of IVGG comparisons

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 0‐30 days Show forest plot	2	327	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.71, 1.01]
Open in figure viewer Analysis 3.1 Comparison 3: Type of IVGG comparisons, Outcome 1: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 0‐30 days
3.2 Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 31‐60 days Show forest plot	2	325	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.49, 1.45]
Open in figure viewer Analysis 3.2 Comparison 3: Type of IVGG comparisons, Outcome 2: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 31‐60 days
3.3 Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities ‐ 180+ days Show forest plot	2	324	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.20, 1.38]
Open in figure viewer Analysis 3.3 Comparison 3: Type of IVGG comparisons, Outcome 3: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities ‐ 180+ days

Comparison 1: IVIG vs control, Outcome 1: CAAs. All total doses. All Children.

Analysis 1.1

Comparison 1: IVIG vs control, Outcome 1: CAAs. All total doses. All Children.

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Comparison 1: IVIG vs control, Outcome 2: CAAs. All total doses. Excluding children with CAAs at diagnosis

Analysis 1.2

Comparison 1: IVIG vs control, Outcome 2: CAAs. All total doses. Excluding children with CAAs at diagnosis

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Comparison 1: IVIG vs control, Outcome 3: CAAs. All total doses. Only children with CAAs at diagnosis.

Analysis 1.3

Comparison 1: IVIG vs control, Outcome 3: CAAs. All total doses. Only children with CAAs at diagnosis.

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Comparison 1: IVIG vs control, Outcome 4: CAAs. All total doses. All children. Studies using recognised diagnostic criteria.

Analysis 1.4

Comparison 1: IVIG vs control, Outcome 4: CAAs. All total doses. All children. Studies using recognised diagnostic criteria.

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Comparison 1: IVIG vs control, Outcome 5: CAAs. All total doses. No CAAs at enrollment. Studies using recognised diagnostic criteria.

Analysis 1.5

Comparison 1: IVIG vs control, Outcome 5: CAAs. All total doses. No CAAs at enrollment. Studies using recognised diagnostic criteria.

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Comparison 1: IVIG vs control, Outcome 6: CAAs. 100 mg/kg total dose. All children

Analysis 1.6

Comparison 1: IVIG vs control, Outcome 6: CAAs. 100 mg/kg total dose. All children

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Comparison 1: IVIG vs control, Outcome 7: CAAs. 500 mg/kg total dose. All children

Analysis 1.7

Comparison 1: IVIG vs control, Outcome 7: CAAs. 500 mg/kg total dose. All children

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Comparison 1: IVIG vs control, Outcome 8: CAAs. 600 mg/kg total dose. All children

Analysis 1.8

Comparison 1: IVIG vs control, Outcome 8: CAAs. 600 mg/kg total dose. All children

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Comparison 1: IVIG vs control, Outcome 9: CAAs. 1200 mg/kg total dose. All children

Analysis 1.9

Comparison 1: IVIG vs control, Outcome 9: CAAs. 1200 mg/kg total dose. All children

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Comparison 1: IVIG vs control, Outcome 10: Duration of fever

Analysis 1.10

Comparison 1: IVIG vs control, Outcome 10: Duration of fever

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Comparison 2: Comparison of dose regimens, Outcome 1: 100 mg/kg x 5 days vs 200 mg/kg x 5 days

Analysis 2.1

Comparison 2: Comparison of dose regimens, Outcome 1: 100 mg/kg x 5 days vs 200 mg/kg x 5 days

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Comparison 2: Comparison of dose regimens, Outcome 2: 100 mg/kg x 5 days vs 400 mg/kg x 5 days

Analysis 2.2

Comparison 2: Comparison of dose regimens, Outcome 2: 100 mg/kg x 5 days vs 400 mg/kg x 5 days

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Comparison 2: Comparison of dose regimens, Outcome 3: 200 mg/kg x 5 days vs 400 mg/kg x 5 days

Analysis 2.3

Comparison 2: Comparison of dose regimens, Outcome 3: 200 mg/kg x 5 days vs 400 mg/kg x 5 days

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Comparison 2: Comparison of dose regimens, Outcome 4: 400 mg/kg x 5 days vs 2 gm/kg single dose

Analysis 2.4

Comparison 2: Comparison of dose regimens, Outcome 4: 400 mg/kg x 5 days vs 2 gm/kg single dose

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Comparison 2: Comparison of dose regimens, Outcome 5: Fever 200 mg/kg x 3 days vs 400 mg/kg/day x 3 days

Analysis 2.5

Comparison 2: Comparison of dose regimens, Outcome 5: Fever 200 mg/kg x 3 days vs 400 mg/kg/day x 3 days

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Comparison 3: Type of IVGG comparisons, Outcome 1: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 0‐30 days

Analysis 3.1

Comparison 3: Type of IVGG comparisons, Outcome 1: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 0‐30 days

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Comparison 3: Type of IVGG comparisons, Outcome 2: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 31‐60 days

Analysis 3.2

Comparison 3: Type of IVGG comparisons, Outcome 2: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 31‐60 days

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Comparison 3: Type of IVGG comparisons, Outcome 3: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities ‐ 180+ days

Analysis 3.3

Comparison 3: Type of IVGG comparisons, Outcome 3: Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities ‐ 180+ days

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Comparison 1. IVIG vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 CAAs. All total doses. All Children. Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1.1 0 to 30 days	10	970	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.61, 0.90]
1.1.2 31 to 60 days	10	1020	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.51, 1.10]
1.1.3 180+ days	6	721	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.28, 1.17]
1.2 CAAs. All total doses. Excluding children with CAAs at diagnosis Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.2.1 0‐30 days	6	521	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.46, 1.00]
1.2.2 31‐60 days	7	527	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.24, 1.04]
1.3 CAAs. All total doses. Only children with CAAs at diagnosis. Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.3.1 0‐30 days	4	445	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.43, 1.28]
1.3.2 31‐60 days	4	446	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.20, 1.73]
1.4 CAAs. All total doses. All children. Studies using recognised diagnostic criteria. Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.4.1 0‐30 days	3	238	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.41, 0.93]
1.4.2 31‐60 days	3	263	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.16, 4.03]
1.5 CAAs. All total doses. No CAAs at enrollment. Studies using recognised diagnostic criteria. Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.5.1 0‐30 days	3	233	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.43, 0.93]
1.5.2 31‐60 days	3	237	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.14, 1.98]
1.6 CAAs. 100 mg/kg total dose. All children Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.6.1 0‐30 days	2	213	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.83, 1.31]
1.6.2 31‐60 days	2	213	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.59, 2.22]
1.6.3 180 days+	2	276	Risk Ratio (M‐H, Random, 95% CI)	1.31 [0.35, 4.92]
1.7 CAAs. 500 mg/kg total dose. All children Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.7.1 0‐30 days	2	283	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.63, 0.84]
1.7.2 31‐60 days	2	276	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.32, 1.01]
1.7.3 180+ days	2	277	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.18, 1.07]
1.8 CAAs. 600 mg/kg total dose. All children Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.8.1 0‐30 days	2	140	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.67, 1.20]
1.8.2 31‐60 days	2	141	Risk Ratio (M‐H, Random, 95% CI)	1.38 [0.59, 3.18]
1.9 CAAs. 1200 mg/kg total dose. All children Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.9.1 0‐30 days	2	175	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.29, 0.92]
1.9.2 31‐60 days	2	175	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.25, 1.71]
1.10 Duration of fever Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.10.1 Duration of fever after initiation of treatment	3	262	Mean Difference (IV, Random, 95% CI)	0.66 [‐4.99, 6.31]

Comparison 1. IVIG vs control

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Comparison 2. Comparison of dose regimens

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 100 mg/kg x 5 days vs 200 mg/kg x 5 days Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1.1 All coronary artery abnormalities ‐ 0‐30 days	2	162	Risk Ratio (M‐H, Random, 95% CI)	1.76 [1.07, 2.89]
2.2 100 mg/kg x 5 days vs 400 mg/kg x 5 days Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.2.1 All coronary artery abnormalities ‐ 0‐30 days	3	401	Risk Ratio (M‐H, Random, 95% CI)	2.79 [1.59, 4.91]
2.2.2 All coronary artery abnormalities ‐ 31‐60 days	2	333	Risk Ratio (M‐H, Random, 95% CI)	3.14 [1.38, 7.15]
2.3 200 mg/kg x 5 days vs 400 mg/kg x 5 days Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.3.1 All coronary artery abnormalities ‐ 0‐30 days	4	623	Risk Ratio (M‐H, Random, 95% CI)	2.44 [1.49, 4.00]
2.4 400 mg/kg x 5 days vs 2 gm/kg single dose Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.4.1 All coronary artery abnormalities ‐ 0‐30 days	2	253	Risk Ratio (M‐H, Random, 95% CI)	4.47 [1.55, 12.86]
2.5 Fever 200 mg/kg x 3 days vs 400 mg/kg/day x 3 days Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

Comparison 2. Comparison of dose regimens

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Comparison 3. Type of IVGG comparisons

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 0‐30 days Show forest plot	2	327	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.71, 1.01]

3.2 Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities 31‐60 days Show forest plot	2	325	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.49, 1.45]

3.3 Intact vs pepsin treated IVIG ‐ Coronary artery abnormalities ‐ 180+ days Show forest plot	2	324	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.20, 1.38]

Comparison 3. Type of IVGG comparisons

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