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

NCT ID: NCT01599611

Last Updated: 2012-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neonatal Hyperbilirubinemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed group

Children age 5-10 years old who had a total serum bilirubin \> 450 umol/L in the neonatal period

Movement assessment battery for children - 2

Intervention Type PROCEDURE

A standardised test developed to identify developmental difficulties in children.

Non-exposed group

Matched 1:1 to the exposed group on gender, age, gestational age and municipality of residence

Movement assessment battery for children - 2

Intervention Type PROCEDURE

A standardised test developed to identify developmental difficulties in children.

Interventions

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Movement assessment battery for children - 2

A standardised test developed to identify developmental difficulties in children.

Intervention Type PROCEDURE

Other Intervention Names

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MABC-2

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pernille Vandborg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Børneafdelingen, Aalborg Sygehus, Denmark

References

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Vandborg PK, Hansen BM, Greisen G, Mathiasen R, Kasper F, Ebbesen F. Follow-up of extreme neonatal hyperbilirubinaemia in 5- to 10-year-old children: a Danish population-based study. Dev Med Child Neurol. 2015 Apr;57(4):378-84. doi: 10.1111/dmcn.12603. Epub 2014 Oct 29.

Reference Type DERIVED
PMID: 25353277 (View on PubMed)

Related Links

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Other Identifiers

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pkv

Identifier Type: -

Identifier Source: org_study_id

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