Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study
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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 |
- 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 |
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
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 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 May 16, 2013