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Neonatal jaundice

were rated EL 1−. IVIG was administered as a single dose (500 mg/kg body weight) over
2 hours in one study, as a single dose (500 mg/kg body weight) over 4 hours in the second, 206
207
as a single dose (500 mg/kg body weight) as soon as possible after birth in the third study, 208 as
three doses (500 mg/kg body weight each) over 4 hours every 12 hours in the fourth study, 209
and as 800 mg/kg body weight per day for 3 days in the final study. 205
Two studies 205;208 included both term and preterm babies while the other three 206;207;209 included
only term babies. Three of the studies 205;207;208 included only babies with Rhesus haemolytic
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disease, one included only babies with ABO haemolytic disease and the fifth 209 included
babies with either Rhesus or ABO haemolytic disease and presented the results for both groups.
The mean birthweight ranged from 2683 ± 292 g to 2834 ± 569 g in four studies 205;206;208;209 and
207
was not reported in the other study. The mean age at entry to study was 20.2 ± 9.5 hours in
209
the one study that reported this. The mean serum bilirubin was 254 ± 57 micromol/litre in the
one study that reported this. The mean gestational age ranged from 36.1 ± 2 weeks to
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209
38 weeks in three studies 205;206;208 and another included only term babies. In the three
studies 206;208;209 that reported on gender, 109 participants (58.3%) were male.
Review findings
Dichotomous outcomes
Indications for exchange transfusion in the studies included serum bilirubin
≥ 340 micromol/litre (two studies), serum bilirubin ≥ 307.8 micromol/litre in babies over
2000 g, serum bilirubin above the Polacek criteria, 210;211 and serum bilirubin rising by 8.5 or
17.1 micromol/litre per hour. Babies randomised to receive IVIG needed statistically
significantly fewer exchange transfusions than controls (RR 0.31, 95% CI 0.20 to 0.47)
(Figure 7.19). Heterogeneity was not significant at I² = 37%.

IVIG Control Risk Ratio Risk Ratio
Study or Subgroup Events Total Events Total Weight M-H, Fixed, 95% CI M-H, Fixed, 95% CI
1.6.1 IVIG
F - Dagoglu 1995 4 22 15 19 24.2% 0.23 [0.09, 0.58]
F - Miqdad 2004 4 56 16 56 24.1% 0.25 [0.09, 0.70]
F - Nasseri 2006 3 17 11 17 16.6% 0.27 [0.09, 0.81]
F - Rubo 1992 2 16 11 16 16.6% 0.18 [0.05, 0.69]
M - Voto 1995 8 19 12 18 18.6% 0.63 [0.34, 1.17]
Subtotal (95% CI) 130 126 100.0% 0.31 [0.20, 0.47]
Total events 21 65
Heterogeneity: Chi² = 6.33, df = 4 (P = 0.18); I² = 37%
Test for overall effect: Z = 5.57 (P < 0.00001)
0.01 0.1 1 10 100
Favours IVIG Favours control
Figure 7.19 Number of exchange transfusions needed when IVIG combined with phototherapy is
compared with phototherapy alone

A post hoc sensitivity analysis examined the effect of IVIG in Rhesus haemolytic disease and
ABO haemolytic disease.
The RR was similar in both Rhesus and ABO haemolytic disease: RR 0.33 (95% CI 0.20 to 0.52)
and RR 0.29 (95% CI 0.13 to 0.68), respectively (Figure 7.20). However, the number needed to
treat (NNT) with IVIG to prevent one exchange transfusion differed in each category of haemolytic
disease. For Rhesus disease the NNT was two while in ABO disease the NNT was five.
The included studies did not report on the adverse effect profile of IVIG.
Continuous outcomes
Only three studies 205;206;209 reported the duration of adjunctive phototherapy. This was
statistically significantly shorter in babies receiving IVIG (MD = −16.46 hours, 95% CI −26.13
to −6.79 hours) (Figure 7.21). Heterogeneity was not a significant factor at I² = 27%.
See the end of Section 7.4 for the overall Evidence summary and GDG translation from
evidence.

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