Page 164 - 16Neonatal Jaundice_compressed

Treatment

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 Rh
F - Dagoglu 1995 4 22 15 19 34.7% 0.23 [0.09, 0.58]
F - Nasseri 2006 1 6 7 7 15.1% 0.23 [0.05, 0.95]
F - Rubo 1992 2 16 11 16 23.7% 0.18 [0.05, 0.69]
M - Voto 1995 8 19 12 18 26.5% 0.63 [0.34, 1.17]
Subtotal (95% CI) 63 60 100.0% 0.33 [0.20, 0.52]
Total events 15 45
Heterogeneity: Chi² = 5.91, df = 3 (P = 0.12); I² = 49%
Test for overall effect: Z = 4.77 (P < 0.00001)
1.6.2 ABO
F - Miqdad 2004 4 56 16 56 79.2% 0.25 [0.09, 0.70]
F - Nasseri 2006 2 11 4 10 20.8% 0.45 [0.10, 1.97]
Subtotal (95% CI) 67 66 100.0% 0.29 [0.13, 0.68]
Total events 6 20
Heterogeneity: Chi² = 0.44, df = 1 (P = 0.51); I² = 0%
Test for overall effect: Z = 2.85 (P = 0.004)
0.01 0.1 1 10 100
Favours IVIG Favours control
Figure 7.20 Number of exchange transfusions needed when IVIG combined with phototherapy is
compared with phototherapy alone – sensitivity analysis based on ABO or Rh haemolysis

IVIG Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
1.4.7 IVIG
F - Miqdad 2004 92 29 56 106 29 56 81.1% -14.00 [-24.74, -3.26]
F - Nasseri 2006 119 23 17 154 48 17 14.6% -35.00 [-60.30, -9.70]
M - Voto 1995 144 72 19 144 72 18 4.3% 0.00 [-46.42, 46.42]
Subtotal (95% CI) 92 91 100.0% -16.46 [-26.13, -6.79]
Heterogeneity: Chi² = 2.75, df = 2 (P = 0.25); I² = 27%
Test for overall effect: Z = 3.34 (P = 0.0008)
-100 -50 0 50 100
Favours IVIG Favours Control
Test for subgroup differences: Not applicable
Figure 7.21 Mean duration of phototherapy when IVIG combined with phototherapy is compared
with phototherapy alone

7.4.2 Other therapies

Clofibrate
Clofibrate is a fibric acid derivative that acts as a lipid-regulating drug. In neonatal
hyperbilirubinaemia its presumed mode of action is by increasing bilirubin conjugation and
excretion.

Description of included studies
From the six articles obtained, one was excluded as the trial was not randomised. Five RCTs
carried out in Iran 212-216 examined clofibrate combined with phototherapy against phototherapy
alone for the treatment of non-haemolytic hyperbilirubinaemia. The evidence level of the
included studies ranged from EL 1− to EL 1++. Three studies 212-214 reported using random
numbers tables as the method of randomisation.

In four studies 213-216 clofibrate was administered in a single oral dose of 100 mg/kg body weight
while in the fifth study 212 it was given in either a low dose of 25 mg/kg body weight or a
moderate dose of 50 mg/kg body weight. This study reported results after the first 24 hours of
treatment while the other RCTs reported up to 96 hours of treatment. This study 212 was
subjected to a sensitivity analysis to ascertain the robustness of the results in terms of
dose/duration of study.
All the studies were carried out in term babies. Where reported, the mean gestational age
ranged from 38.7 ± 0.9 weeks to 38.8 ± 1.6 weeks, the mean birthweight ranged from
2542 ± 547 g to 3259 ± 481 g, the mean age at entry to study ranged from 123 ± 55 hours to
216 ± 94.8 hours, the mean serum bilirubin ranged from 301 ± 23.4 micromol/litre to
395 ± 58 micromol/litre, and 145 (53.7%) of the sample were male.

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