Reducing bilirubin induced neurological dysfunction in preterm infants: additional use of the bilirubin:albumin ratio in the treatment of hyperbilirubinemia.
- Conditions
- English: Infants premature, preterm infant, hyperbilirubinemia, bilirubin:albumin ratio, albumin. BIND, bilirubin induced neurological dysfunction. Neurodevelopmental outcome.Nederlands: prematuur, prematuriteit, hyperbilirubinemie, bilirubine:albumine ratio, albumine, BIND, bilirubine geinduceerde neurologische dysfunctie. Neurologische ontwikkeling.
- Registration Number
- NL-OMON26621
- Lead Sponsor
- eonatology, Beatrix Children's Hospital, UMC Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 614
Inclusion Criteria
1. 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 Criteria
1. Major congenital malformations, clinical syndromes and chromosomal abnormalities that effect neurodevelopmental outcome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blinded assessment of the participants outcome is performed. <br>Primary outcome: <br>1. Neurodevelopmental outcome at the age of 18-24 months using standardised neurological examination;<br>2. Mental - and psychomotor developmental index scores (MDI and PDI: Dutch version of Bayley scales of infant development II) <br>
- Secondary Outcome Measures
Name Time Method Secondary outcome: <br>1. Peak total serum bilirubin, duration of hyperbilirubinemia, duration of fototherapy, number of exchange transfusions;<br>2. Other outcomes are: complications of prematurity such as mortality, BPD, PDA, BPD, ROP, NEC, IVH ect.; <br>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 NICU’s that are able to perform serial ABR’s. free (unbound) unconjugated bilirubin, lumirubin, CFM, movement scores