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NCT01599611 Clinical Trial

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

Neonatal Hyperbilirubinemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01599611
Other study ID # pkv
Secondary ID
Status Completed
Phase N/A
First received May 14, 2012
Last updated May 15, 2012
Start date March 2010
Est. completion date January 2011

Study information
Verified date May 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 10 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Movement assessment battery for children - 2
A standardised test developed to identify developmental difficulties in children.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Outcome
Type Measure Description Time frame Safety issue
Primary Motor development Delayed motor development for children in the exposed group compared to children in the non-exposed group Age 5-10 years No
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