Actively Recruiting
European Newborn Study: Early Markers for a Better LifE
Led by dr. M.J.N.L. Benders · Updated on 2025-09-24
1000
Participants Needed
8
Research Sites
273 weeks
Total Duration
On this page
Sponsors
D
dr. M.J.N.L. Benders
Lead Sponsor
F
Fondation Paralysie Cérébrale
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 provide better care to future babies. Next to this, the experiences of parents or caregivers surrounding the first two years after birth of a baby at risk of developing cerebral palsy will be researched to develop recommendations to support parents. Parents of participants will: \- Fill in two online questionnaires, one when their child is 3-4 months corrected age. The second when their child is 2 years corrected age. For the child no additional tests are needed. Only tests that are part of standard clinical practice are performed and are also saved in the study database.
CONDITIONS
Official Title
European Newborn Study: Early Markers for a Better LifE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants with confirmed brain injury on MRI at high risk for cerebral palsy
- Brain injury identified by MRI at term equivalent age or within 10 days after birth or sentinel event
- Specific brain injuries including extensive punctate white matter injury, periventricular hemorrhagic infarction, cerebellar injury involving vermis or more than one-third of cerebellar hemisphere, cystic periventricular leukomalacia grade 3 or 4, intraventricular hemorrhages grade III
- Posthemorrhagic ventricular dilatation exceeding the 97th percentile plus 4 mm for ventricular index
- Perinatal asphyxia with hypoxic ischemic injury of central gray matter, perirolandic area, or watershed areas
- Perinatal ischemic arterial stroke at high risk for cerebral palsy involving corticospinal tracts, cortex, white matter, and basal ganglia
- Other brain injuries expected to cause adverse motor outcomes including large subdural or parenchymal bleedings with or without midline shift, bilirubin induced brain injury
- Written informed parental consent in Dutch, English, French, German, Italian, or Spanish
You will not qualify if you...
- Infants not meeting the inclusion criteria
- Proven or suspected severe congenital anomaly, genetic or metabolic disorder
- Infection of the central nervous system
- Parents younger than 18 years old
- Inability to read one of the six informed consent languages (Dutch, English, French, German, Italian, Spanish)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Assistance Publique Hôpitaux de Paris
Paris, France
Actively Recruiting
2
University Hospital Essen
Essen, Germany
Actively Recruiting
3
Ospedale Pediatrico Meyer Firenze
Florence, Italy
Actively Recruiting
4
Istituto Giannina Gaslini
Genova, Italy
Not Yet Recruiting
5
Ospedale Maggiore di Milano
Milan, Italy
Actively Recruiting
6
Fondazione Stella Maris
Pisa, Italy
Actively Recruiting
7
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
8
University Hospital La Paz
Madrid, Spain
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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