Reorganisation of the sensorimotor cortex following early unilateral brain damage

Completed

• Conditions: 10010335; neonatal stroke; 10028920; 10047075

• Registration Number: NL-OMON41354
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

A) preterm infants with a gestational age < 37 weeks admitted to the level III neonatal intensive care unit of the Wilhelmina Children*s Hospital, UMC Utrecht, between 1990 and 2000 with (1) a unilateral PH which subsequently did or did not result in hemiplegic cerebral palsy, and (2) an MRI during the neonatal period and often also at 24 months of age. Group (B): term infants >=37 weeks gestation admitted to our level III neonatal intensive care unit with 1) neonatal encephalopathy and/or seizures and diagnosed to have PAIS which subsequently did or did not result in hemiplegic cerebral palsy, and (2) an MRI during the neonatal period and often also at 24 months of age. Starting from the first of january 2011 we will also include children with CP due to a PAIS who were referred to the VU medical centre in Amsterdam. They will be studied in the UMCU. Furthermore we will continue including children who fulfill the inclusion criteria as mentioned earlier, but also included children at the age of six years and older.
In 2015, an additional five patients will be included. These patients were previously too young to be included, but have now reached the age of six years or older.

Exclusion Criteria

Preterm infants with lesions affecting both hemispheres, like periventricular leukomalacia. Fullterm infants with lesions affecting both hemispheres, such as injury to the central grey nuclei or watershed injury, occurring in infants with hypoxic-ischemic encephalopathy
Infants with congenital anomalies, chromosomal disorders, or infections of the central nervous system are also not eligible for the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Outcome measures<br /><br>Primary outcome measure: nature of reorganisation, defined as *intra-<br /><br>hemispheric reorganisation* or *inter-hemispheric reorganisation* and relation<br /><br>between reorganisation and *functional outcome*, assessed with gross- and fine<br /><br>motor developmental status (see methods).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>