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限制液体量治疗早产儿慢性肺病

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Referencias

References to studies included in this review

Fewtrell 1997 {published data only}

Fewtrell MS, Adams C, Wilson DC, Cairns P, Mcclure G, Lucas A. Randomized trial of high nutrient density formula versus standard formula in chronic lung disease. Acta Paediatrica. 1997;86(6):577‐82. [PUBMED: 9202790]CENTRAL

Additional references

Bancalari 2002

Bancalari E. Neonatal chronic lung disease. In: Fanaroff A, Martin R editor(s). Neonatal‐Perinatal Medicine. 7th Edition. Vol. 2, St. Louis, Missouri: Mosby Inc, 2002:1057‐70.

Bell 1998

Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database of Systematic Reviews 1998, Issue 4. [DOI: 10.1002/14651858.CD000503]

Brown 1978

Brown ER, Stark A, Sosenko I, Lawson EE, Avery ME. Bronchopulmonary dysplasia: possible relationship to pulmonary edema. Journal of Pediatrics 1978;92(6):982‐4. [PUBMED: 660373]

GRADEpro [Computer program]

McMaster University. GRADEpro [available from www.gradepro.org]. McMaster University, 2014.

Gregory 2005

Gregory K. Update on nutrition for preterm and full‐term infants. Journal of Obstetric, Gynecologic, and Neonatal Nursing 2005;34(1):98‐108. [PUBMED: 15673653]

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.

Jobe 2011

Jobe AH. The New Bronchopulmonary Dysplasia. Current Opinion in Pediatrics 2011;23(2):167‐72. [PUBMED: 21169836]

Kao 1983

Kao LC, Warburton D, Sargent CW, Platzker AC, Keens TG. Furosemide acutely decreases airway resistance in chronic bronchopulmonary dysplasia. Journal of Pediatrics 1983;103(4):624‐9. [PUBMED: 6620024]

McCann 1985

McCann EM, Lewis K, Deming DD, Donovan MJ, Brady JP. Controlled trial of furosemide therapy in infants with chronic lung disease. Journal of Pediatrics 1985;106(6):957‐62. [PUBMED: 3889258]

Niermeyer 1988

Niermeyer S. Nutritional and metabolic problems in infants with bronchopulmonary dysplasia. In: Bancalari E, Stocker JT editor(s). Bronchopulmonary dysplasia. Washington: Hemisphere Publishing Corporation, 1988.

Northway 1967

Northway WH, Rosan RC, Porter DY. Pulmonary disease following respirator therapy of hyaline‐membrane disease. Bronchopulmonary dysplasia. New England Journal of Medicine 1967;276(7):357‐68. [PUBMED: 5334613]

Schünemann 2013

Schünemann H, Brożek J, Guyatt G, Oxman A, editors. GRADE Working Group. GRADE handbook for grading quality of evidence and strength of recommendations. Available from www.guidelinedevelopment.org/handbookupdated October 2013.

Viswanathan 2015

Viswanathan S, McNelis K, Super D, Einstadter D, Groh‐Wargo S, Collin M. Standardized slow enteral feeding protocol and the incidence of necrotizing enterocolitis in extremely low birth weight infants. JPEN. Journal of Parenteral and Enteral Nutrition 2015;39(6):644‐54. [PUBMED: 25316681]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Fewtrell 1997

Methods

Randomised controlled trial

Participants

60 preterm infants < 1500 grams and < 32 weeks, dependent on oxygen at more than 28 days of age

Interventions

Standard formula (24 kcal/oz) at 180 mL/kg/day compared to high nutrient‐density formula (30 kcal/oz) at 145 mL/kg/day

Outcomes

Growth variables, respiratory outcomes.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Pre‐determined randomisation sequence in block of 4 and 6.

Allocation concealment (selection bias)

Low risk

Randomisation sequences maintained in opaque envelopes.

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not feasible to mask the intervention.

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome measures done by a research nurse not blind to the dietary randomisation.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All subjects accounted for in the results.

Selective reporting (reporting bias)

Unclear risk

No published or registered protocol was found.

Other bias

Unclear risk

The lack on concealment may have had an impact on the intervention itself: the medical staff were apparently reluctant to increase daily fluids, so the high‐volume group did not receive as much fluid as planned.

Funding Source

Unclear risk

Study was funded by industry (Ross Laboratories) who also created the formulae. No indication is given about other roles of the funding source.

Data and analyses

Open in table viewer
Comparison 1. Fluid restricted compared to liberal fluids

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Duration of hospitalisation Show forest plot

1

60

Mean Difference (IV, Fixed, 95% CI)

3.0 [‐7.64, 13.64]

Analysis 1.1

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 1 Duration of hospitalisation.

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 1 Duration of hospitalisation.

2 Daily weight gain Show forest plot

1

60

Mean Difference (IV, Fixed, 95% CI)

0.5 [‐1.22, 2.22]

Analysis 1.2

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 2 Daily weight gain.

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 2 Daily weight gain.

3 Proportion with apnoea Show forest plot

1

60

Risk Difference (M‐H, Fixed, 95% CI)

0.22 [‐0.00, 0.44]

Analysis 1.3

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 3 Proportion with apnoea.

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 3 Proportion with apnoea.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 1 Duration of hospitalisation.
Figuras y tablas -
Analysis 1.1

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 1 Duration of hospitalisation.

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 2 Daily weight gain.
Figuras y tablas -
Analysis 1.2

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 2 Daily weight gain.

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 3 Proportion with apnoea.
Figuras y tablas -
Analysis 1.3

Comparison 1 Fluid restricted compared to liberal fluids, Outcome 3 Proportion with apnoea.

Summary of findings for the main comparison. Fluid restricted compared to liberal fluids compared to placebo for treatment of preterm babies with chronic lung disease

Fluid restricted compared to liberal fluids compared to placebo for treatment of preterm babies with chronic lung disease

Participant or population: treatment of preterm babies with chronic lung disease
Setting:
Intervention: Fluid restricted compared to liberal fluids
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with fluid restricted compared to liberal fluids

Duration of oxygen therapy

The mean duration of oxygen therapy was 27.5 days

median 0.5 days higher
(0 to 0 )

60
(1 RCT)

⊕⊕⊝⊝
LOW 1 2

Duration of hospitalisation

The mean duration of hospitalisation was 85 days

MD 3 Days higher
(7.64 lower to 13.64 higher)

60
(1 RCT)

⊕⊕⊝⊝
LOW 1 2

Daily weight gain

The mean daily weight gain was 14.8 g/kg/d

MD 0.5 g/kg/d higher
(1.22 lower to 2.22 higher)

60
(1 RCT)

⊕⊕⊝⊝
LOW 1 2

Proportion with apnoea

Study population

RR 1.35
(0.98 to 1.86)

60
(1 RCT)

⊕⊕⊝⊝
LOW 1 2

630 per 1000

850 per 1000
(617 to 1000)

Moderate

630 per 1000

850 per 1000
(617 to 1000)

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: Confidence interval; RR: Risk ratio; OR: Odds ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect

1 Unmasked study

2 Wide confidence limits

Figuras y tablas -
Summary of findings for the main comparison. Fluid restricted compared to liberal fluids compared to placebo for treatment of preterm babies with chronic lung disease
Comparison 1. Fluid restricted compared to liberal fluids

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Duration of hospitalisation Show forest plot

1

60

Mean Difference (IV, Fixed, 95% CI)

3.0 [‐7.64, 13.64]

2 Daily weight gain Show forest plot

1

60

Mean Difference (IV, Fixed, 95% CI)

0.5 [‐1.22, 2.22]

3 Proportion with apnoea Show forest plot

1

60

Risk Difference (M‐H, Fixed, 95% CI)

0.22 [‐0.00, 0.44]

Figuras y tablas -
Comparison 1. Fluid restricted compared to liberal fluids