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Brain Injury in Moderate Preterm Neonates

Brain Injury in Moderate Preterm Neonates - BIMP

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41869
Enrollment
254
Registered
2019-07-12
Start date
2017-08-15
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 injury

Interventions

Brain damage
Moderate preterm
Neonates

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1. Born prematurely, gestational age 32-36 weeks; 2. Admission to the neonatal high care or medium care unit.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Presence/absence of brain injury on cUS at day 3 and/or 7 and/or on cUS and/or MRI at TEA (composite endpoint of all diagnostic modalities and time points).

Secondary

MeasureTime frame
1. Maternal factors 2. Intra-partum factors 3. Infant factors 4. Presence/absence of brain injury on cUS at day 3 5. Presence/absence of brain injury on cUS at day 7 6. Presence/absence of brain injury on cUS and/or MRI at TEA 7. Presence/absence of abnormal findings at neurological examination at TEA 8. Presence/absence of abnormal neurodevelopmental outcome at 2 years of age

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)