Immunoglobulin for alloimmune hemolytic disease in neonates

Carolien Zwiers; Mirjam EA Scheffer‐Rath; Enrico Lopriore; Masja de Haas; Helen G Liley

doi:10.1002/14651858.CD003313.pub2

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Figure 1

Flow diagram of study selection process. IVIg: intravenous immunoglobulin; RCT: randomized controlled trial.

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Figure 2

Risk of bias summary: review authors' judgments about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Intravenous immunoglobulin plus phototherapy versus phototherapy, Outcome 1 Use of exchange transfusion (≥ 1).

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Analysis 1.2

Comparison 1 Intravenous immunoglobulin plus phototherapy versus phototherapy, Outcome 2 Exchange transfusions per infant, by study quality.

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Analysis 1.3

Comparison 1 Intravenous immunoglobulin plus phototherapy versus phototherapy, Outcome 3 Use of top‐up transfusion in 1st week by study quality.

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Analysis 1.4

Comparison 1 Intravenous immunoglobulin plus phototherapy versus phototherapy, Outcome 4 Top‐up transfusions in 1st week per infant by study quality.

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Analysis 1.5

Comparison 1 Intravenous immunoglobulin plus phototherapy versus phototherapy, Outcome 5 Use of top‐up transfusion after 1st week by study quality.

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Analysis 1.6

Comparison 1 Intravenous immunoglobulin plus phototherapy versus phototherapy, Outcome 6 Top‐up transfusions after first week per infant, by study quality.

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Analysis 1.7

Comparison 1 Intravenous immunoglobulin plus phototherapy versus phototherapy, Outcome 7 Maximum total serum bilirubin (µmol/L) by study quality.

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Analysis 1.8

Comparison 1 Intravenous immunoglobulin plus phototherapy versus phototherapy, Outcome 8 Duration of phototherapy (days) by study quality.

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Analysis 2.1

Comparison 2 Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only, Outcome 1 Use of exchange transfusion (≥ 1).

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Analysis 2.2

Comparison 2 Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only, Outcome 2 Exchange transfusions per infant.

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Analysis 2.3

Comparison 2 Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only, Outcome 3 Use top‐up transfusion in 1st week.

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Analysis 2.4

Comparison 2 Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only, Outcome 4 Top‐up transfusions in 1st week per infant.

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Analysis 2.5

Comparison 2 Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only, Outcome 5 Use of top‐up transfusion after 1st week.

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Analysis 2.6

Comparison 2 Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only, Outcome 6 Top‐up transfusions after 1st week per infant.

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Analysis 2.7

Comparison 2 Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only, Outcome 7 Maximum total serum bilirubin (µmol/L).

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Analysis 2.8

Comparison 2 Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only, Outcome 8 Duration of phototherapy (days).

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Analysis 3.1

Comparison 3 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth, Outcome 1 Use of exchange transfusion (≥ 1).

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Analysis 3.2

Comparison 3 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth, Outcome 2 Exchange transfusions per infant.

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Analysis 3.3

Comparison 3 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth, Outcome 3 Use of top‐up transfusion in 1st week.

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Analysis 3.4

Comparison 3 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth, Outcome 4 Top‐up transfusions in 1st week per infant.

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Analysis 3.5

Comparison 3 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth, Outcome 5 Use of top‐up transfusions after 1st week.

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Analysis 3.6

Comparison 3 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth, Outcome 6 Top‐up transfusions after 1st week per infant.

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Analysis 3.7

Comparison 3 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth, Outcome 7 Maximum total serum bilirubin (µmol/L).

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Analysis 3.8

Comparison 3 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth, Outcome 8 Duration of phototherapy (days).

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Analysis 4.1

Comparison 4 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg, Outcome 1 Use of exchange transfusion (≥ 1).

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Analysis 4.2

Comparison 4 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg, Outcome 2 Exchange transfusions per infant.

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Analysis 4.3

Comparison 4 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg, Outcome 3 Use of top‐up transfusions in 1st week.

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Analysis 4.4

Comparison 4 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg, Outcome 4 Top‐up transfusions in 1st week per infant.

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Analysis 4.5

Comparison 4 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg, Outcome 5 Use of top‐up transfusion after 1st week.

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Analysis 4.6

Comparison 4 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg, Outcome 6 Top‐up transfusions after 1st week per infant.

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Analysis 4.7

Comparison 4 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg, Outcome 7 Maximum total serum bilirubin (µmol/L).

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Analysis 4.8

Comparison 4 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg, Outcome 8 Duration of phototherapy (days).

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Analysis 5.1

Comparison 5 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Multiple doses of IVIg, Outcome 1 Use of exchange transfusion (≥ 1).

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Analysis 5.2

Comparison 5 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Multiple doses of IVIg, Outcome 2 Exchange transfusions per infant.

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Analysis 5.3

Comparison 5 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Multiple doses of IVIg, Outcome 3 Use of top‐up transfusions after 1st week.

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Analysis 5.4

Comparison 5 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Multiple doses of IVIg, Outcome 4 Duration of phototherapy (days).

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Analysis 6.1

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 1 Use of exchange transfusion (≥ 1).

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Analysis 6.2

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 2 Exchange transfusions per infant.

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Analysis 6.3

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 3 Use of top‐up transfusion in 1st week.

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Analysis 6.4

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 4 Top‐up transfusions in 1st week per infant.

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Analysis 6.5

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 5 Use of top‐up transfusion after 1st week.

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Analysis 6.6

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 6 Top‐up transfusions after 1st week per infant.

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Analysis 6.7

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 7 Maximum total serum bilirubin (µmol/L).

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Analysis 6.8

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 8 Duration of phototherapy (days).

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Analysis 6.9

Comparison 6 Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks, Outcome 9 Duration of hospitalization (days).

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Summary of findings for the main comparison. Intravenous immunoglobulin plus phototherapy compared to phototherapy alone for alloimmune hemolytic disease in neonates

Intravenous immunoglobulin plus phototherapy compared to phototherapy alone for alloimmune hemolytic disease in neonates
Patient or population: neonates with alloimmune hemolytic disease Settings: ‐ Intervention: IVIg + phototherapy Comparison: phototherapy
Outcomes	№ of participants (studies)	Quality of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Risk with phototherapy alone	Risk difference with IVIg + phototherapy
Use of ET (≥ 1); all studies	658 (9 RCTs)	⊕⊝⊝⊝ Very low^1,2,3	RR 0.35 (0.25 to 0.49)	Study population
				329 per 1000	214 fewer per 1000 (247 fewer to 168 fewer)
Use of ET (≥ 1); placebo‐controlled studies	172 (2 RCTs)	⊕⊕⊕⊝ Moderate⁴	RR 0.98 (0.48 to 1.98)	Study population
				153 per 1000	3 fewer per 1000 (80 fewer to 150 more)
ETs performed per infant; all studies	658 (9 RCTs)	⊕⊝⊝⊝ Very low^1,2,3,5	‐	The mean ETs per infant for all studies was 0	MD 0.34 lower (0.5 lower to 0.17 lower)
ETs performed per infant; placebo‐controlled studies	172 (2 RCTs)	⊕⊕⊕⊝ Moderate^4,5	‐	The mean ETs per infant for placebo‐controlled studies was 0	MD 0.04 lower (0.18 lower to 0.1 higher)
Use of top‐up transfusion in 1st week of life; all studies	378 (4 RCTs)	⊕⊕⊝⊝ Low^6,7	RR 1.05 (0.65 to 1.69)	Study population
				130 per 1000	6 more per 1000 (45 fewer to 89 more)
Use of top‐up transfusion after 1st week of life; all studies	507 (7 RCTs)	⊕⊝⊝⊝ Very low^1,8,9	RR 1.16 (0.97 to 1.38)	Study population
				219 per 1000	35 more per 1000 (7 fewer to 83 more)
Maximum total serum bilirubin (µmol/L); all studies	451 (6 RCTs)	⊕⊝⊝⊝ Very low^10,11,12	‐	The mean maximum serum bilirubin (µmol/L) for all studies was 0	MD 25.39 lower (34.07 lower to 16.7 lower)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; ET: exchange transfusion; IVIg: intravenous immunoglobulin; MD: mean difference; RCT: randomized controlled trial; RR: risk 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.
¹In three studies, the method of randomization was not stated and there was inadequate concealment of random sequence (selection bias). In seven studies, there was no blinding of personnel (performance bias) and in five studies, no blinding of outcome assessment (detection bias). Among other potential sources of bias were that mean bilirubin levels at study entry were already higher than the threshold for the outcome (ET) in one study, differences between study groups despite randomization (one study), postrandomization withdrawals or cross‐over between study groups (two studies) and criteria for ET differing between treatment arms (one study). ²Substantial heterogeneity: Chi² = 34.63, df = 8 (P = 0.0003), I² = 77%. ³Four studies did not clearly specify use of intensive phototherapy (which should be a routine intervention for infants at high risk of ET). ⁴Total number of participants in these two trials was low, increasing the risk of possible bias. ⁵Only a few infants needed a second ET. ⁶In one trial, the methods of randomization and allocation concealment were not stated. In two studies, there was no blinding of personnel (performance bias). ⁷Combined studies were underpowered for use of top‐up transfusion in 1st week. A total of 378 infants were enrolled in all four trials, and the overall frequency of top‐up transfusion was low (13.8%). ⁸Substantial heterogeneity: Chi² = 15.60, df = 5 (P = 0.008); I² = 68%. ⁹Due to small differences between treatment groups, the combined studies were underpowered for use of top‐up transfusion after 1st week. ¹⁰Four studies used no method of blinding the intervention. ¹¹Substantial heterogeneity: Chi² = 14.82, df = 5 (P = 0.01); I² = 66%. ¹²Peak serum bilirubin in the control group varied 1.86‐fold between studies; there was considerably greater variation between studies than between groups within studies.

Summary of findings for the main comparison. Intravenous immunoglobulin plus phototherapy compared to phototherapy alone for alloimmune hemolytic disease in neonates

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Comparison 1. Intravenous immunoglobulin plus phototherapy versus phototherapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Use of exchange transfusion (≥ 1) Show forest plot	9	658	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.25, 0.49]

1.1 Studies without a placebo group	7	486	Risk Ratio (M‐H, Fixed, 95% CI)	0.26 [0.18, 0.39]
1.2 Placebo‐controlled studies	2	172	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.48, 1.98]
2 Exchange transfusions per infant, by study quality Show forest plot	9	658	Mean Difference (IV, Random, 95% CI)	‐0.34 [‐0.50, ‐0.17]

2.1 Studies without a placebo group	7	486	Mean Difference (IV, Random, 95% CI)	‐0.44 [‐0.64, ‐0.25]
2.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.18, 0.10]
3 Use of top‐up transfusion in 1st week by study quality Show forest plot	4	378	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.65, 1.69]

3.1 Studies without a placebo group	2	206	Risk Ratio (M‐H, Fixed, 95% CI)	0.71 [0.24, 2.12]
3.2 Placebo‐controlled studies	2	172	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.70, 2.00]
4 Top‐up transfusions in 1st week per infant by study quality Show forest plot	3	262	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.07, 0.17]

4.1 Studies without a placebo group	1	90	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.07, 0.17]
5 Use of top‐up transfusion after 1st week by study quality Show forest plot	7	507	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.97, 1.38]

5.1 Studies without a placebo group	5	335	Risk Ratio (M‐H, Fixed, 95% CI)	1.40 [1.08, 1.82]
5.2 Placebo‐controlled studies	2	172	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.80, 1.27]
6 Top‐up transfusions after first week per infant, by study quality Show forest plot	4	316	Mean Difference (IV, Fixed, 95% CI)	‐0.00 [‐0.12, 0.12]

6.1 Studies without a placebo group	2	144	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	‐0.00 [‐0.12, 0.12]
7 Maximum total serum bilirubin (µmol/L) by study quality Show forest plot	6	451	Mean Difference (IV, Fixed, 95% CI)	‐25.39 [‐34.07, ‐16.70]

7.1 Studies without a placebo group	4	279	Mean Difference (IV, Fixed, 95% CI)	‐29.05 [‐38.32, ‐19.78]
7.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	0.93 [‐23.94, 25.79]
8 Duration of phototherapy (days) by study quality Show forest plot	7	585	Mean Difference (IV, Random, 95% CI)	‐0.98 [‐1.31, ‐0.66]

8.1 Studies without a placebo group	5	413	Mean Difference (IV, Random, 95% CI)	‐1.06 [‐1.41, ‐0.72]
8.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Random, 95% CI)	‐0.50 [‐1.24, 0.24]

Comparison 1. Intravenous immunoglobulin plus phototherapy versus phototherapy

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Comparison 2. Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Use of exchange transfusion (≥ 1) Show forest plot	7	371	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.25, 0.58]

1.1 Studies without a placebo group	5	199	Risk Ratio (M‐H, Fixed, 95% CI)	0.23 [0.13, 0.40]
1.2 Placebo‐controlled studies	2	172	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.48, 1.98]
2 Exchange transfusions per infant Show forest plot	7	371	Mean Difference (IV, Fixed, 95% CI)	‐0.25 [‐0.34, ‐0.16]

2.1 Studies without a placebo group	5	199	Mean Difference (IV, Fixed, 95% CI)	‐0.39 [‐0.51, ‐0.28]
2.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	‐0.04 [‐0.18, 0.10]
3 Use top‐up transfusion in 1st week Show forest plot	4	285	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.65, 1.77]

3.1 Studies without a placebo group	2	113	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.10, 2.51]
3.2 Placebo‐controlled studies	2	172	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.70, 2.00]
4 Top‐up transfusions in 1st week per infant Show forest plot	3	262	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.07, 0.17]

4.1 Studies without a placebo group	1	90	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.07, 0.17]
5 Use of top‐up transfusion after 1st week Show forest plot	6	281	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.92, 1.28]

5.1 Studies without a placebo group	4	109	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.96, 1.53]
5.2 Placebo‐controlled studies	2	172	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.80, 1.27]
6 Top‐up transfusions after 1st week per infant Show forest plot	3	204	Mean Difference (IV, Fixed, 95% CI)	‐0.00 [‐0.12, 0.12]

7 Maximum total serum bilirubin (µmol/L) Show forest plot	6	358	Mean Difference (IV, Fixed, 95% CI)	‐21.77 [‐30.86, ‐12.67]

7.1 Studies without a placebo group	4	186	Mean Difference (IV, Fixed, 95% CI)	‐25.27 [‐35.04, ‐15.50]
7.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	0.92 [‐23.94, 25.79]
8 Duration of phototherapy (days) Show forest plot	5	298	Mean Difference (IV, Fixed, 95% CI)	‐1.23 [‐1.43, ‐1.02]

8.1 Studies without a placebo group	3	126	Mean Difference (IV, Fixed, 95% CI)	‐1.28 [‐1.49, ‐1.07]
8.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	‐0.50 [‐1.24, 0.24]

Comparison 2. Intravenous immunoglobulin plus phototherapy versus phototherapy. Rh incompatibility only

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Comparison 3. Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Use of exchange transfusion (≥ 1) Show forest plot	5	335	Risk Ratio (M‐H, Fixed, 95% CI)	0.41 [0.26, 0.66]

1.1 Studies without a placebo group	3	163	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.11, 0.42]
1.2 Placebo‐controlled studies	2	172	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.48, 1.98]
2 Exchange transfusions per infant Show forest plot	5	335	Mean Difference (IV, Fixed, 95% CI)	‐0.19 [‐0.28, ‐0.10]

2.1 Studies without a placebo group	3	163	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.42, ‐0.18]
2.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	‐0.04 [‐0.18, 0.10]
3 Use of top‐up transfusion in 1st week Show forest plot	3	262	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.70, 2.00]

4 Top‐up transfusions in 1st week per infant Show forest plot	3	262	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.07, 0.17]

5 Use of top‐up transfusions after 1st week Show forest plot	4	245	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.89, 1.22]

6 Top‐up transfusions after 1st week per infant Show forest plot	3	204	Mean Difference (IV, Fixed, 95% CI)	‐0.00 [‐0.12, 0.12]

7 Maximum total serum bilirubin (µmol/L) Show forest plot	5	335	Mean Difference (IV, Fixed, 95% CI)	‐20.57 [‐29.81, ‐11.33]

7.1 Studies without a placebo group	3	163	Mean Difference (IV, Fixed, 95% CI)	‐24.01 [‐33.96, ‐14.06]
7.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	0.92 [‐23.94, 25.79]
8 Duration of phototherapy (days) Show forest plot	3	262	Mean Difference (IV, Fixed, 95% CI)	‐1.24 [‐1.44, ‐1.03]

8.1 Studies without a placebo group	1	90	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐1.51, ‐1.09]
8.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	‐0.50 [‐1.24, 0.24]

Comparison 3. Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. IVIg administration ≤ 12 hours after birth

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Comparison 4. Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Use of exchange transfusion (≥ 1) Show forest plot	7	563	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.26, 0.53]

1.1 Studies without a placebo group	5	391	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.17, 0.42]
1.2 Placebo‐controlled studies	2	172	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.48, 1.98]
2 Exchange transfusions per infant Show forest plot	7	563	Mean Difference (IV, Fixed, 95% CI)	‐0.21 [‐0.28, ‐0.14]

2.1 Studies without a placebo group	5	391	Mean Difference (IV, Fixed, 95% CI)	‐0.27 [‐0.36, ‐0.19]
2.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	‐0.04 [‐0.18, 0.10]
3 Use of top‐up transfusions in 1st week Show forest plot	4	378	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.65, 1.69]

4 Top‐up transfusions in 1st week per infant Show forest plot	3	262	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.07, 0.17]

5 Use of top‐up transfusion after 1st week Show forest plot	6	473	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.95, 1.33]

6 Top‐up transfusions after 1st week per infant Show forest plot	4	316	Mean Difference (IV, Fixed, 95% CI)	‐0.00 [‐0.12, 0.12]

7 Maximum total serum bilirubin (µmol/L) Show forest plot	6	451	Mean Difference (IV, Fixed, 95% CI)	‐25.39 [‐34.07, ‐16.70]

7.1 Studies without a placebo group	4	279	Mean Difference (IV, Fixed, 95% CI)	‐29.05 [‐38.32, ‐19.78]
7.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	0.92 [‐23.94, 25.79]
8 Duration of phototherapy (days) Show forest plot	5	490	Mean Difference (IV, Fixed, 95% CI)	‐1.12 [‐1.30, ‐0.94]

8.1 Studies without a placebo group	3	318	Mean Difference (IV, Fixed, 95% CI)	‐1.16 [‐1.34, ‐0.97]
8.2 Placebo‐controlled studies	2	172	Mean Difference (IV, Fixed, 95% CI)	‐0.50 [‐1.24, 0.24]

Comparison 4. Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Single dose of IVIg

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Comparison 5. Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Multiple doses of IVIg

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Use of exchange transfusion (≥ 1) Show forest plot	1	34	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.09, 0.81]

2 Exchange transfusions per infant Show forest plot	1	34	Mean Difference (IV, Fixed, 95% CI)	‐0.94 [‐1.45, ‐0.43]

3 Use of top‐up transfusions after 1st week Show forest plot	1	34	Odds Ratio (M‐H, Fixed, 95% CI)	5.65 [0.25, 126.87]

4 Duration of phototherapy (days) Show forest plot	1	34	Mean Difference (IV, Fixed, 95% CI)	‐1.47 [‐2.52, ‐0.42]

Comparison 5. Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Multiple doses of IVIg

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Comparison 6. Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Use of exchange transfusion (≥ 1) Show forest plot	6	391	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.25, 0.61]

1.1 Studies without a placebo group	4	301	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.18, 0.49]
1.2 Placebo‐controlled studies	2	90	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.49, 6.42]
2 Exchange transfusions per infant Show forest plot	6	391	Mean Difference (IV, Fixed, 95% CI)	‐0.17 [‐0.26, ‐0.08]

2.1 Studies without a placebo group	4	301	Mean Difference (IV, Fixed, 95% CI)	‐0.25 [‐0.36, ‐0.15]
2.2 Placebo‐controlled studies	2	90	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.12, 0.22]
3 Use of top‐up transfusion in 1st week Show forest plot	4	296	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.48, 1.74]

4 Top‐up transfusions in 1st week per infant Show forest plot	3	180	Mean Difference (IV, Fixed, 95% CI)	‐0.01 [‐0.35, 0.33]

5 Use of top‐up transfusion after 1st week Show forest plot	4	240	Risk Ratio (M‐H, Fixed, 95% CI)	1.18 [0.81, 1.71]

6 Top‐up transfusions after 1st week per infant Show forest plot	2	90	Mean Difference (IV, Fixed, 95% CI)	‐0.03 [‐0.20, 0.13]

7 Maximum total serum bilirubin (µmol/L) Show forest plot	4	296	Mean Difference (IV, Fixed, 95% CI)	‐26.81 [‐35.97, ‐17.65]

7.1 Studies without a placebo group	2	206	Mean Difference (IV, Fixed, 95% CI)	‐30.33 [‐39.83, ‐20.82]
7.2 Placebo‐controlled studies	2	90	Mean Difference (IV, Fixed, 95% CI)	19.47 [‐15.00, 53.94]
8 Duration of phototherapy (days) Show forest plot	6	391	Mean Difference (IV, Fixed, 95% CI)	‐1.20 [‐1.38, ‐1.01]

8.1 Studies without a placebo group	4	301	Mean Difference (IV, Fixed, 95% CI)	‐1.25 [‐1.44, ‐1.06]
8.2 Placebo‐controlled studies	2	90	Mean Difference (IV, Fixed, 95% CI)	0.18 [‐0.75, 1.12]
9 Duration of hospitalization (days) Show forest plot	5	330	Mean Difference (IV, Fixed, 95% CI)	‐1.33 [‐1.59, ‐1.07]

9.1 Studies without a placebo group	3	240	Mean Difference (IV, Fixed, 95% CI)	‐1.37 [‐1.63, ‐1.10]
9.2 Placebo‐controlled studies	2	90	Mean Difference (IV, Fixed, 95% CI)	‐0.32 [‐1.69, 1.05]

Comparison 6. Intravenous immunoglobulin (IVIg) plus phototherapy versus phototherapy. Gestational age ≥ 37 weeks

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