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

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.

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Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

Acute intermediate or advanced bilirubin encephalopathy

Treatment and study plan

Movement assessment battery for children - 2

Procedure

A standardised test developed to identify developmental difficulties in children.

Other names: MABC-2

Primary outcomes

Motor development

Time frame: Age 5-10 years

Delayed motor development for children in the exposed group compared to children in the non-exposed group

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: May 16, 2012
Registry last updated: May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed