Reducing bilirubin-induced neurological dysfunction in preterm infants: additional use of the Bilirubin:Albumin Ratio in the treatment of hyperbilirubinemia

Not Applicable

Completed

• Conditions: Hyperbilirubinemia, bilirubin induced neurological dysfunction; Nervous System Diseases; Neurological dysfunction

• Registration Number: ISRCTN74465643
• Lead Sponsor: niversity Medical Centre Groningen (UMCG) (The Netherlands)

Brief Summary

Meeting abstracts: 1. van Imhoff, DE; Dijk, PH; Bos, AF, et al. (2007) Dutch thresholds for unconjugated hyperbilirubinemia in preterm infants: when should treatment be started? ACTA PAEDIATRICA 96: 197-197 2. V W van den Belt, M van der Heide, D E van Imhoff, A F Bos, P H Dijk, C V Hulzebos, and Bart Studygroup (2008) IRRADIANCE LEVELS OF PHOTOTHERAPY IN JAUNDICED PRETERM INFANTS. Arch. Dis. Child. 93: p252 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18450807 2013 hearing loss results in https://pubmed.ncbi.nlm.nih.gov/23667532/ (added 12/04/2021) 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24927259

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-11
• Study Completion: 2010-04-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 614

Inclusion Criteria

1. Preterm infants born at gestational age less than 32 weeks, either sex
2. Admittance in the first 24 hours of life to a neonatal intensive care unit care centre in the Netherlands

Exclusion Criteria

Major congenital malformations, clinical syndromes and chromosomal abnormalities that affect neurodevelopmental outcome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Blinded assessment of the participants outcome is performed.<br><br> Primary outcome:<br> 1. Neurodevelopmental outcome at the age of 18 to 24 months using standardised neurological examination will be measured from October 2008 till April 2010<br> 2. Mental- and Psychomotor Developmental Index scores (MDI and PDI: Dutch version of Bayley scales of infant development II) will be measured from October 2008 till April 2010<br>