Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study

Completed

• Conditions: Neonatal Hyperbilirubinemia
• Interventions: Procedure: Movement assessment battery for children - 2

• Registration Number: NCT01599611
• Lead Sponsor: University of Aarhus

Brief Summary

The objective of this study was to investigate whether infants with total serum bilirubin \> 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.

Detailed Description

Children in both the exposed and the non-exposed group were examined by use of the MABC-2 and pure tone audiometry by the responsible examiner for the study, Pernille Vandborg, MD. The aim was to see whether the exposed group suffered any long term sequelae to the extreme neonatal hyperbilirubinemia, i.e. impaired motor development or hearing impairment, compared to a control group. The examinations took place at the local hospital.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Last Update Submitted: 2012-05-15
• Study First Posted: 2012-05-16
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Gestational age > 35 weeks
• Total serum bilirubin > 450 umol/L in the neonatal period
• Born in the period 01.01.2000 - 31.12.2005

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Exclusion Criteria

• Acute intermediate or advanced bilirubin encephalopathy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed group	Movement assessment battery for children - 2	Children age 5-10 years old who had a total serum bilirubin \> 450 umol/L in the neonatal period
Non-exposed group	Movement assessment battery for children - 2	Matched 1:1 to the exposed group on gender, age, gestational age and municipality of residence

Primary Outcome Measures

Name	Time	Method
Motor development	Age 5-10 years	Delayed motor development for children in the exposed group compared to children in the non-exposed group