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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01599611
First received: May 14, 2012
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Neonatal Hyperbilirubinemia
Procedure: Movement assessment battery for children - 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Motor development [ Time Frame: Age 5-10 years ] [ Designated as safety issue: No ]
    Delayed motor development for children in the exposed group compared to children in the non-exposed group


Enrollment: 128
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exposed group
Children age 5-10 years old who had a total serum bilirubin > 450 umol/L in the neonatal period
Procedure: Movement assessment battery for children - 2
A standardised test developed to identify developmental difficulties in children.
Other Name: MABC-2
Non-exposed group
Matched 1:1 to the exposed group on gender, age, gestational age and municipality of residence
Procedure: Movement assessment battery for children - 2
A standardised test developed to identify developmental difficulties in children.
Other Name: MABC-2

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.

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01599611

Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Pernille Vandborg, MD, PhD Børneafdelingen, Aalborg Sygehus, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01599611     History of Changes
Other Study ID Numbers: pkv
Study First Received: May 14, 2012
Last Updated: May 15, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Neonatal hyperbilirubinemia
Follow-up
Motor development
Hearing
Executive function

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 26, 2014