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

May 14, 2012
May 15, 2012
March 2010
January 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01599611 on ClinicalTrials.gov Archive Site
Not Provided
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Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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

Neonatal Hyperbilirubinemia
Procedure: Movement assessment battery for children - 2
A standardised test developed to identify developmental difficulties in children.
Other Name: MABC-2
  • Exposed group
    Children age 5-10 years old who had a total serum bilirubin > 450 umol/L in the neonatal period
    Intervention: Procedure: Movement assessment battery for children - 2
  • Non-exposed group
    Matched 1:1 to the exposed group on gender, age, gestational age and municipality of residence
    Intervention: Procedure: Movement assessment battery for children - 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
5 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01599611
pkv
No
University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Pernille Vandborg, MD, PhD Børneafdelingen, Aalborg Sygehus, Denmark
University of Aarhus
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP