Preterm brain injury, long-term outcome and brain development study

Preterm brain injury, long-term outcome and brain development study - PROUD study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47239

Enrollment

110

Registered

2018-08-21

Start date

2017-09-16

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

brain development Preterm brain injury

Interventions

Brain development

Brain injury

Outcome

Preterm birth

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: VPT children (GA

Exclusion criteria

Exclusion criteria: Lack of informed consent of parents (including parental refusal or unable to explain because of language barrier) Congenital or acquired abnormalities of the central nervous system, other than those caused by preterm birth Any medical condition, device or implant that pauses a safety issue for MRI examination (exclusion for MRI investigation) Children in whom a proper preparation for the MRI or EEG procedure is not possible because of severe motor, behavioural or cognitive handicaps or severe anxiety (both for MRI and EEG examination)

Design outcomes

Primary

Measure	Time frame
Relationship between common structural neonatal MRI abnormalities (white matter injury and cerebellar injury) and neurodevelopmental outcome on different domains (i.e. neuromotor outcome, cognitive outcome, neuropsychological outcome, executive functions and behavioural outcome) 9-10 years after preterm birth. Relationship between neonatal MRI findings and brain development (i.e. brain tissue growth and markers of brain maturation ) and connectivity (EEG and fMRI) 10 years after preterm birth.	—

Measure

Time frame

Relationship between common structural neonatal MRI abnormalities (white matter injury and cerebellar injury) and neurodevelopmental outcome on different domains (i.e. neuromotor outcome, cognitive outcome, neuropsychological outcome, executive functions and behavioural outcome) 9-10 years after preterm birth. Relationship between neonatal MRI findings and brain development (i.e. brain tissue growth and markers of brain maturation ) and connectivity (EEG and fMRI) 10 years after preterm birth.

—

Secondary

Measure	Time frame
Relationship between brain development and connectivity 9-10 years after preterm birth and motor, cognitive, neuropsychological, executive and behavioural functioning.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)