- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599611
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
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:
|
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.
Sponsor
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.
Helpful Links
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pkv
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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