Page 21 - 16Neonatal Jaundice_compressed

Guidance summary

include adverse effects, family adjustment, breastfeeding effects, parental bonding and anxiety,
staff and parental satisfaction with treatment and cost effectiveness. Time stamp: Sept 2009

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

1.6 Treatment threshold graphs

The graphs on pages 14–29 show the gestational age specific thresholds for inititiating and
stopping treatment. An electronic interactive implementation tool for treatment thresholds is
available at www.nice.org.uk/guidance/CG98.

1.7 Investigation, phototherapy and exchange transfusion pathways

The pathways for investigation, phototherapy and exchange transfusion are on pages 30–32.

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