Comparison of school-age outcome in children with a history of perinatal asphyxia with and without hypothermia therapy with controls

Completed

• Conditions: perinatal asphyxia; 10010335; 10028920

• Registration Number: NL-OMON47459
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

a) 40 full-term infants admitted to a NICU (UMCU or Isala) in the period of
2007-2008 because of acute perinatal asphyxia but without hypothermia
and
b) 40 fullterm infants admitted to a NICU (UMCU or Isala) in the period of
2008-2009 because of acute perinatal asphyxia but treated with hypothermia

Exclusion Criteria

- Moderate to severe structural brain damage previously confirmed by MRI;
- Congenital brain abnormalities and/or other (chromosomal/metabolic) anomalies;
- Cerebral palsy;
- Abnormal developmental outcome (DQ<85) at 2 years of age
- Birth weight <10th percentile;
- Contraindications for MRI, such as braces, a pacemaker or claustrophobia.
- Epilepsy (this only applies fo the virtual realty glasses)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Neuropsychological assessment:<br /><br>comparison of neurospychological outcome assessed at 9-10 years of age in<br /><br>children who suffered perinatal asphyxia, were treated /or not with hypothermia<br /><br>in the neonatal period<br /><br><br /><br>MRI.<br /><br>Conventional MR imaging will be evaluated for presence of structural<br /><br>abnormalities. From the resting-state fMRI sequence, cross-correlation<br /><br>calculations between resting-state time series of spatially distant brain areas<br /><br>can determine functional connectivity (FC) between brain areas. Next to network<br /><br>localization, network size and FC strength will be studied.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>MRI<br /><br>Comparison of cross-correlation calculations between resting-state time series<br /><br>of spatially distant brain areas can determine functional connectivity (FC)<br /><br>between brain areas. Next to network localization, network size and FC strength<br /><br>will be studied in infants with and without perinatal asphyxia.<br /><br>Comparison of the results of the neuropsychological evaluation with the results<br /><br>of the test using the virtual reality glasses. . </p><br>