Cerebral injury after neonatal cardiac surgery: Outcome at school age

Cerebral injury after neonatal cardiac surgery: Outcome at school age - Cerebral injury after neonatal cardiac surgery: Outcome at school age

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45739

Enrollment

Registered

2017-05-03

Start date

2017-10-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart disease

Interventions

cardiac surgery

cerebral

neonatal

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the prevalence of an abnormal MRI scan in this cohort.	—

Secondary

Measure	Time frame
* Have the lesions seen at a neonatal age changed, and are there new lesions? * Is the connectivity different (decreased) in children post-cardiac surgery, compared to healthy children? * Do children with lesions on their MRI have less connectivity compared to those without injury? * Do more lesions lead to a smaller brain volume? * Does MRI injury relate to neurodevelopment? * Does functional connectivity relate to neurodevelopment? * Is the impact of perinatal asphyxia different to neonatal cardiac surgery, on the MRI of the brain at school age?	—

Measure

Time frame

* Have the lesions seen at a neonatal age changed, and are there new lesions? * Is the connectivity different (decreased) in children post-cardiac surgery, compared to healthy children? * Do children with lesions on their MRI have less connectivity compared to those without injury? * Do more lesions lead to a smaller brain volume? * Does MRI injury relate to neurodevelopment? * Does functional connectivity relate to neurodevelopment? * Is the impact of perinatal asphyxia different to neonatal cardiac surgery, on the MRI of the brain at school age?

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)