European Newborn Study: Early Markers for a Better LifE

Recruiting now

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT07189494

Run by

dr. M.J.N.L. Benders

People needed

1000

Starts

2023-10-06

Expected to finish

2029-01-01

Last updated by the study team

2025-09-24

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University Hospital La Paz — Madrid, Spain (enrolling)
• University Hospital Essen — Essen, Germany (enrolling)
• Ospedale Pediatrico Meyer Firenze — Florence, Italy (enrolling)
• Assistance Publique Hôpitaux de Paris — Paris, France (enrolling)
• Ospedale Maggiore di Milano — Milan, Italy (enrolling)
• Fondazione Stella Maris — Pisa, Italy (enrolling)
• UMC Utrecht — Utrecht, Netherlands (enrolling)
• Istituto Giannina Gaslini — Genova, Italy

Full record on ClinicalTrials.gov

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