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

May 15, 2012 updated by: University of Aarhus
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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children born in Denmark in the period 01.01.2000 - 31.12.2005 with a gestational age >= 35 weeks and a total serum bilirubin > 450 umol/L and a matched control group of children

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposed group
Children age 5-10 years old who had a total serum bilirubin > 450 umol/L in the neonatal period
A standardised test developed to identify developmental difficulties in children.
Other Names:
  • MABC-2
Non-exposed group
Matched 1:1 to the exposed group on gender, age, gestational age and municipality of residence
A standardised test developed to identify developmental difficulties in children.
Other Names:
  • MABC-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Age 5-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pernille Vandborg, MD, PhD, Børneafdelingen, Aalborg Sygehus, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimate)

May 16, 2012

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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