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

NCT01599611 | Completed

• 1 other identifier: pkv
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Hyperbilirubinemia

Keywords

Neonatal hyperbilirubinemia; Follow-up; Motor development; Hearing; Executive function

Outcome Measures

Primary Outcomes (1)

• Motor development

  Delayed motor development for children in the exposed group compared to children in the non-exposed group

  Age 5-10 years

Study Arms (2)

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

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

Interventions

Movement assessment battery for children - 2 PROCEDURE

A standardised test developed to identify developmental difficulties in children.

Also known as: MABC-2

Exposed group; Non-exposed group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Gestational age \> 35 weeks
• Total serum bilirubin \> 450 umol/L in the neonatal period
• Born in the period 01.01.2000 - 31.12.2005

You may not qualify if:

• Acute intermediate or advanced bilirubin encephalopathy

Sponsors & Collaborators

• University of Aarhus: lead

Related Publications (1)

• 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.

  PMID: 25353277 DERIVED

Related Links

• A description of the study in Danish

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pernille Vandborg, MD, PhD

  Børneafdelingen, Aalborg Sygehus, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 16, 2012

Record last verified: 2012-05