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

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ClinicalTrials.gov Identifier: NCT01599611
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Neonatal Hyperbilirubinemia Procedure: Movement assessment battery for children - 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.

Study Design

Study Type : Observational
Actual Enrollment : 128 participants
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
Study Start Date : March 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice
U.S. FDA Resources

Groups and Cohorts

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
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599611


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01599611     History of Changes
Other Study ID Numbers: pkv
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

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