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BARTrial


Link to PhD thesis of Deirdre van Imhoff

 

BARTrial

Reducing bilirubin induced neurological dysfunction in preterm infants: additional use of bilirubin/albumin ratio in the treatment of hyperbilirubinemia.

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Introduction:
Neonatal jaundice due to unconjugated hyperbilirubinemia occurs frequently in preterm infants. Severe hyperbilirubinemia is neurotoxic and can result in severe encephalopathy (i.e. kernicterus) or more subtle bilirubin encephalopathy (i.e. bilirubin induced neurological dysfunction (BIND)). Treatment strategies (phototherapy and exchange transfusion) are based on total serum bilirubin, but are not evidence based. Total serum bilirubin is an unreliable parameter in the prediction of bilirubin encephalopathy. In contrast, non-albumin bound unconjugated bilirubin (i.e., free bilirubin (Bf)), which can pass the blood - brain barrier, correlates better with bilirubin neurotoxicity. Unfortunately, Bf can not be measured routinely. The bilirubin/albumin ratio is considered a surrogate parameter for Bf. Low albumin levels (i.e. a high B/A ratio) can result in high Bf levels, and potentiate BIND. The additional use of the B/A ratio together with TSB is an interesting parameter in the management of hyperbilirubinemia in preterm infants.

Objective:
Reducing BIND by using the B/A ratio together with TSB in the treatment of hyperbilirubinemia in preterm infants.

Study design:
Prospective, randomized, controlled, open label, blinded outcome cost - effectiveness multicenter study in all tertiary neonatal intensive care units (n=10) in the Netherlands.

Study population:
614 preterm infants will be included in 9 months in 10 NICUs. Inclusion criteria are: gestational age < 32 weeks, admitted to a NICU within 24 hours after birth and without clinical suspicion for chromosomal or syndromal abnormalities.

Intervention:
Hyperbilirubinemia is evaluated daily using B/A ratio together with TSB (study group) versus TSB only (control group). Treatment guidelines are based on B/A ratio and TSB (whichever comes first) in the study group versus TSB only in the control group.

Endpoints:
The primary outcomes are the neurodevelopmental index scores at 18 - 24 months of age. Secondary outcomes are: peak TSB, peak B/A ratio, free bilirubin, number and duration of phototherapy, number of exchange transfusion, transcutane bilirubin and complications of prematurity such as mortality. Cost effectiveness is also an outcome of this study.

Time schedule:
Inclusion time of 9 months, starting in may 2007. Follow up at 18 to 24 months of age. Total duration of the study is 36 months, ending May 2010.