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


- candidate number2520
- NTR NumberNTR935
- ISRCTNISRCTN74465643
- Date ISRCTN created11-apr-2007
- date ISRCTN requested24-mrt-2007
- Date Registered NTR13-mrt-2007
- Secondary IDs 
- Public TitleReducing bilirubin induced neurological dysfunction in preterm infants: additional use of the bilirubin:albumin ratio in the treatment of hyperbilirubinemia.
- Scientific TitleReducing bilirubin induced neurological dysfunction in preterm infants: additional use of the bilirubin:albumin ratio in the treatment of hyperbilirubinemia.
- ACRONYMBARTrial
- hypothesisNeonatal jaundice due to unconjugated hyperbilirubinemia occurs in almost all preterm infants and is potentially neurotoxic. The current treatment modalities (phototherapy and exchange transfusion) are based on total serum bilirubin (TSB) levels, but are not evidence based. TSB is an unreliable predictor of bilirubin induced neurological dysfunction (BIND). Because low albumin levels appear tot potentiate BIND, the bilirubin:albumin (B:A) ratio is an interesting additional factor to assess in the management of preterm infants with hyperbilirubinemia.
- Healt Condition(s) or Problem(s) studiedPremature infants, Prematurity, Hyperbilirubinemia, Bilirubin:albumin ratio, Bilirubin, Neurodevelopmental outcome
- Inclusion criteria1. Preterm infants born at gestational age less than 32 weeks; 2. Admittance in the first 24 hours of life to a neonatal intensive care unit care center in the Netherlands.
- Exclusion criteria1. Major congenital malformations, clinical syndromes and chromosomal abnormalities that effect neurodevelopmental outcome.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-apr-2010
- Target number of participants614
- InterventionsStudygroup: Hyperbilirubinemia is evaluated daily, in the first 10 days of life using the B:A ratio together with TSB. Treatment guidelines (phototherapy and exchange transfusion limits) are based on B:A ratio and TSB (whichever comes first) Controlgroup: Hyperbilirubinemia is evaluated daily, in the first 10 days of life using TSB only (care as usual). versus only TSB. Treatment guidelines (phototherapy and exchange transfusion limits) are based on TSB only.
- Primary outcomeBlinded assessment of the participants outcome is performed. Primary outcome: 1. Neurodevelopmental outcome at the age of 18-24 months using standardised neurological examination; 2. Mental - and psychomotor developmental index scores (MDI and PDI: Dutch version of Bayley scales of infant development II)
- Secondary outcomeSecondary outcome: 1. Peak total serum bilirubin, duration of hyperbilirubinemia, duration of fototherapy, number of exchange transfusions; 2. Other outcomes are: complications of prematurity such as mortality, BPD, PDA, BPD, ROP, NEC, IVH ect.; 3. Other potential outcomes to be evaluated in parts of the study population are: maturation pattern of serial auditory brainstem responses (ABR) in a part of the study populations that is treated in those NICUís that are able to perform serial ABRís. free (unbound) unconjugated bilirubin, lumirubin, CFM, movement scores
- Timepoints
- Trial web sitehttp://www.neonatologiestudies.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Deirdre Imhoff van
- CONTACT for SCIENTIFIC QUERIES Peter Dijk
- Sponsor/Initiator University Medical Center Groningen (UMCG), Beatrix Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryIntroduction: Neonatal jaundice due to unconjugated hyperbilirubinemia occurs in almost all preterm infants and is potentially neurotoxic. The current treatment modalities (phototherapy and exchange transfusion) are based on total serum bilirubin (TSB) levels, but are not evidence based. TSB is an unreliable predictor of bilirubin induced neurological dysfunction (BIND). Because low albumin levels appear tot potentiate BIND, the bilirubin:albumin (B:A) ratio is an interesting additional factor to assess in the management of preterm infants with hyperbilirubinemia. Research Question: Does the additional use of the B:A ratio together with TSB reduce BIND in comparison to TSB only, in the management of preterm infants with hyperbiliburinemia? Study design: prospective randomised controlled open label, blinded outcom multicenter cost-effectiveness multicenter study in tertiary neonatal intensive care units in the Netherlands. Study population: preterm infants < 32wks GA. Intervention: hyperbilirubinemia is evaluated daily using the B:A ratio together with TSB (studygroup) versus TSB only (control or care-as-usual-group). Treatment guidelines are based on B:A ratio and TSB (whichever comes first) versus only TSB. Outcome: primairy: Neurodevelopmental outcome at 18-24 months of age (MDI/PDI) secondairy: bilirubine associated parameters, standard complications of prematurity, Cost-effectiveness. Other potential outcomes: ABR, lumirubin. free-bilirubin, TcB.
- Main changes (audit trail)
- RECORD13-mrt-2007 - 12-apr-2007


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