Cerebral injury after neonatal cardiac surgery: Outcome at school age
Completed
- Conditions
- congenital heart disease100103941001033510007593
- Registration Number
- NL-OMON45739
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Was a participant in the RCT study from 2009-2012
- Has an age of 8 or 9 years.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- If there is a contra-indication for MRI scan (certain types of cardiac devices, braces).
- If the child is unwilling to undergo the MRI scan, due to i.e. claustrophobia.
- In the case of a known genetic syndrome associated with developmental delay.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> The primary endpoint is the prevalence of an abnormal MRI scan in this cohort.<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>* Have the lesions seen at a neonatal age changed, and are there new lesions?<br /><br>* Is the connectivity different (decreased) in children post-cardiac surgery,<br /><br>compared to healthy children?<br /><br>* Do children with lesions on their MRI have less connectivity compared to<br /><br>those without injury?<br /><br>* Do more lesions lead to a smaller brain volume?<br /><br>* Does MRI injury relate to neurodevelopment?<br /><br>* Does functional connectivity relate to neurodevelopment?<br /><br>* Is the impact of perinatal asphyxia different to neonatal cardiac surgery, on<br /><br>the MRI of the brain at school age? </p><br>