Status:
RECRUITING
European Newborn Study: Early Markers for a Better LifE
Lead Sponsor:
dr. M.J.N.L. Benders
Collaborating Sponsors:
Fondation Paralysie Cérébrale
Zoundream
Conditions:
Cerebral Palsy
Eligibility:
All Genders
Up to 2 years
Brief Summary
The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury. This will help p...
Eligibility Criteria
Inclusion
- All infants with confirmed brain injury on MRI at high risk for CP.
- Particularly, infants with the following brain injuries at risk for CP will be considered on MRI at term equivalent age or within 10 days after birth or sentinel event:
- Extensive punctate white matter injury.
- Periventricular hemorrhagic infarction (any location).
- Cerebellar injury (ischemic and/or hemorrhages) involving the vermis or involving more than 1/3 of the cerebellar hemisphere and/or lesions involving the cerebellar vermis (Meijler \& Steggerda, 2019).
- Cystic periventricular leukomalacia (grade 3 \& 4).
- intraventricular hemorrhages grade III.
- Posthemorrhagic ventricular dilatation exceeding the 97°percentile + 4mm for the ventricular index (Cizmeci et al., 2020).
- Perinatal asphyxia with hypoxic ischemic injury of the central gray matter and/or perirolandic area.
- Perinatal asphyxia with hypoxic ischemic injury in the watershed areas.
- Perinatal ischemic arterial stroke at high risk for CP, thus with involvement of the corticospinal tracts, cortex, white matter and basal ganglia (Wagenaar et al., 2018).
- Presence of other brain injuries with expected adverse motor outcome (i.e. big subdural and parenchymal bleedings with/without midline shift, bilirubin induced brain injury) in preterm infants, term infants with neonatal encephalopathy with/without neonatal seizures.
- Written informed parental consent (Dutch, English, French, German, Italian, Spanish).
Exclusion
- Infants not matching the inclusion criteria.
- Any proven or suspected severe congenital anomaly, genetic or metabolic disorder.
- Presence of an infection of the central nervous system.
- Parents \< 18 years old.
- Not being able to read one of the six Informed Consent languages.
Key Trial Info
Start Date :
October 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07189494
Start Date
October 6 2023
End Date
January 1 2029
Last Update
September 24 2025
Active Locations (8)
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1
Assistance Publique Hôpitaux de Paris
Paris, France
2
University Hospital Essen
Essen, Germany
3
Ospedale Pediatrico Meyer Firenze
Florence, Italy
4
Istituto Giannina Gaslini
Genova, Italy