Page 166 - 16Neonatal Jaundice_compressed

Treatment

Clofibrate Control Mean Difference Mean Difference
Study or Subgroup Mean SD Total Mean SD Total Weight IV, Fixed, 95% CI IV, Fixed, 95% CI
F - Eghbalian 2007 53.6 15 30 68.8 21.6 30 42.9% -15.20 [-24.61, -5.79]
F - Mohammadzadeh 2005 30 12.9 30 54 18.8 30 57.1% -24.00 [-32.16, -15.84]
Total (95% CI) 60 60 100.0% -20.22 [-26.39, -14.06]
Heterogeneity: Chi² = 1.92, df = 1 (P = 0.17); I² = 48%
-50
50
Test for overall effect: Z = 6.43 (P < 0.00001) -100 Favours Clofibrate 0 Favours Control 100
Figure 7.25 Mean duration of phototherapy when clofibrate combined with phototherapy is
compared with phototherapy alone – sensitivity analysis based on dosage

See the end of Section 7.4 for the overall Evidence summary and GDG translation from
evidence.
Riboflavin

Description of included studies
From the four articles obtained, one was excluded as the study reported was not randomised.
Three RCTs 217-219 from Hungary, 218 Turkey 219 and the USA 217 compared riboflavin in
combination with phototherapy with phototherapy alone for the treatment of
hyperbilirubinaemia. One study 217 used random numbers to allocate treatment but did not
report on allocation concealment and so was rated EL 1+. Neither of the other two studies 218;219
reported either randomisation method or allocation concealment and so were rated EL 1−.
Where reported, the mean birthweight ranged from 3230 ± 502 g to 3338 ± 425 g, the mean
age at entry to study ranged from 50.2 ± 27.2 hours to 71.3 ± 24.1 hours, and the mean serum
bilirubin was 358 ± 71 micromol/litre. In one study 217 that reported gender, 12 participants
(50%) were male. The mean gestational age was not reported.
Review findings

Dichotomous outcomes
None of the studies reported on either the number of exchange transfusions needed or the
adverse effect profile of riboflavin.
Continuous outcomes
In one RCT 217 (n = 24) from the USA, riboflavin (sodium phosphate 1.5 mg/kg body weight
every 12 hours) was given for 6 hours prior to phototherapy for the treatment of non-haemolytic
hyperbilirubinaemia in term babies. Riboflavin was discontinued after 24 hours of
phototherapy. In babies randomised to riboflavin there was a mean reduction (not statistically
significant) in serum bilirubin after 24 hours (MD = −17.00 micromol/litre, 95% CI −35.81 to
1.81 micromol/litre). [EL 1+]
In the second RCT 219 (n = 124), from Turkey, riboflavin was given as a single oral dose of
3 mg/kg body weight within 30 minutes of starting phototherapy in the treatment of term babies
with non-haemolytic hyperbilirubinaemia. Babies receiving riboflavin showed a statistically
significant reduction in mean serum bilirubin after 24 hours (MD = −30.00 micromol/litre,
95% CI −49.20 to −10.80 micromol/litre). There was no statistically significant difference
regarding mean duration of phototherapy. [EL 1−]

The third RCT 218 (n = 28), from Hungary, evaluated riboflavin given as an intravenous dose of
10 mg/kg body weight for the treatment of haemolytic hyperbilirubinaemia in term babies being
prepared for exchange transfusion. Bilirubin concentrations fell in the riboflavin group and rose
in the control group, resulting in a statistically significantly greater difference between the
groups in serum bilirubin after 3 hours (MD = −119.00 micromol/litre, 95% CI −154.62 to
−83.38 micromol/litre). [EL 1−].
See the end of Section 7.4 for the overall Evidence summary and GDG translation from
evidence.

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