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Treatment

Research recommendations

What is the effectiveness, cost-effectiveness and safety of Clofibrate alongside phototherapy
versus phototherapy alone for non-haemolytic significant hyperbilirubinaemia?
Why this is important.
Existing research has demonstrated that Clofibrate in combination with phototherapy can
shorten time spent undergoing phototherapy. This can help minimise the disruption to
breastfeeding and mother-baby bonding. However no studies have been carried out in a UK
population. New placebo-controlled double-blind randomised controlled trials in a UK
population are needed. Population: Term and preterm babies with significant
hyperbilirubinaemia in the first 28 days of life. Interventions: Clofibrate (a single 100mg/kg
dose) combined with phototherapy versus phototherapy with a placebo. Outcome:
Effectiveness in terms of mean decrease in bilirubin levels and mean duration of phototherapy.
Extra outcomes should include adverse effects, parental bonding and parental anxiety, staff and
parental satisfaction with treatment and cost effectiveness. Time stamp: Sept 2009
What is the clinical and cost-effectiveness of IVIG when used to prevent exchange
transfusion in newborns with haemolytic disease and rising bilirubin?

Why this is important.
Existing research has demonstrated that IVIG is effective in preventing the need for an
exchange transfusion in babies with Rhesus haemolysis. New placebo-controlled double-
blind randomised controlled trials are needed to examine if IVIG is effective in sub-groups of
babies with ABO haemolysis, ie preterm babies, babies with bilirubin rising greater than
10 micromol/litre per hour or babies with co-morbid illnesses such as infections. Population:
Term and preterm babies with significant hyperbilirubinaemia in the first 28 days of life.
Interventions: IVIG (500mg/kg over 4 hours) alongside phototherapy versus phototherapy
alone. Outcome: Number of exchange transfusions needed. Extra outcomes should include
adverse effects, mean duration of phototherapy, parental anxiety, staff and parental
satisfaction with treatment and cost effectiveness. Time stamp: Sept 2009

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