European Newborn Study: Early Markers for a Better LifE
NCT ID: NCT07189494
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2023-10-06
2029-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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).
* 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.
0 Years
2 Years
ALL
No
Sponsors
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Fondation Paralysie Cérébrale
OTHER
Zoundream
UNKNOWN
CP Nederland
UNKNOWN
NeuroSpin
UNKNOWN
dr. M.J.N.L. Benders
OTHER
Responsible Party
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dr. M.J.N.L. Benders
Prof. dr.
Locations
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Assistance Publique Hôpitaux de Paris
Paris, , France
University Hospital Essen
Essen, , Germany
Ospedale Pediatrico Meyer Firenze
Florence, , Italy
Istituto Giannina Gaslini
Genova, , Italy
Ospedale Maggiore di Milano
Milan, , Italy
Fondazione Stella Maris
Pisa, , Italy
UMC Utrecht
Utrecht, , Netherlands
University Hospital La Paz
Madrid, , Spain
Countries
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Facility Contacts
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Associate Professor of Child Neurology and Psychiatry
Role: primary
Role: backup
Role: backup
Associate Professor at Clinical Sciences and Community Health
Role: primary
professor of paediatric neurology at the University of Pisa
Role: primary
Other Identifiers
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NL83183.041.22
Identifier Type: -
Identifier Source: org_study_id
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