Early brain markers in newborns at risk for cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multicenter European effort will collect routine clinical data and MRI findings from newborns with brain injuries and store them in a shared database to train machine learning models. No extra tests are required for the child beyond standard clinical care, while parents complete two online questionnaires at 3–4 months and at 2 years corrected age. The study aims to combine imaging, clinical course, and parent-reported experience to identify early markers that predict later developmental outcomes. Findings will be used to develop practical recommendations to support families and guide early follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Assistance Publique Hôpitaux de Paris
  Paris, France Recruiting
• University Hospital Essen
  Essen, Germany Recruiting
• Ospedale Pediatrico Meyer Firenze
  Florence, Italy Recruiting
• Ospedale Maggiore di Milano
  Milan, Italy Recruiting
• Fondazione Stella Maris
  Pisa, Italy Recruiting
• UMC Utrecht
  Utrecht, Netherlands Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.