Brain Injury in Moderate Preterm Neonates
Recruiting
- Conditions
- Brain injury1002929910010335
- Registration Number
- NL-OMON41869
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 254
Inclusion Criteria
1. Born prematurely, gestational age 32-36 weeks;
2. Admission to the neonatal high care or medium care unit.
Exclusion Criteria
1. Congenital malformations of the central nervous system;
2. Chromosomal disorders;
3. Inborn errors of metabolism;
4. Congenital infections;
5. Central nervous system infections;
6. Brain injury acquired after the neonatal period
7. Parents do not speak Dutch or English
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Presence/absence of brain injury on cUS at day 3 and/or 7 and/or on cUS and/or<br /><br>MRI at TEA (composite endpoint of all diagnostic modalities and time points).</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Maternal factors<br /><br>2. Intra-partum factors<br /><br>3. Infant factors<br /><br>4. Presence/absence of brain injury on cUS at day 3<br /><br>5. Presence/absence of brain injury on cUS at day 7<br /><br>6. Presence/absence of brain injury on cUS and/or MRI at TEA<br /><br>7. Presence/absence of abnormal findings at neurological examination at TEA<br /><br>8. Presence/absence of abnormal neurodevelopmental outcome at 2 years of age</p><br>