New computer model could predict cerebral palsy in babies
NCT ID NCT07189494
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to build a computer model that helps doctors predict developmental problems in babies diagnosed with brain injury, especially those at risk for cerebral palsy. Researchers will collect data from standard medical tests and ask parents to fill out two online questionnaires over two years. No extra tests are needed for the babies. The goal is to improve care and support for families.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will include all preterm and term born infants with any brain injury at risk for CP admitted to the neonatal intensive of 8 large European NICUs, high and medium care units, including their parents. Based on a conservative estimate and taking into account incidence of in/exclusion criteria, we expect to include 1000 eligible patients in a total inclusion period of 2.5 years.
- Ages
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0 to 2 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assistance Publique Hôpitaux de Paris
RECRUITINGParis, France
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Fondazione Stella Maris
RECRUITINGPisa, Italy
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Istituto Giannina Gaslini
NOT_YET_RECRUITINGGenova, Italy
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Ospedale Maggiore di Milano
RECRUITINGMilan, Italy
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Ospedale Pediatrico Meyer Firenze
RECRUITINGFlorence, Italy
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UMC Utrecht
RECRUITINGUtrecht, Netherlands
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University Hospital Essen
RECRUITINGEssen, Germany
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University Hospital La Paz
RECRUITINGMadrid, Spain
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