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New computer model could predict cerebral palsy in babies

NCT ID NCT07189494

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

0 to 2 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    8 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Assistance Publique Hôpitaux de Paris

    RECRUITING

    Paris, France

  • Fondazione Stella Maris

    RECRUITING

    Pisa, Italy

  • Istituto Giannina Gaslini

    NOT_YET_RECRUITING

    Genova, Italy

  • Ospedale Maggiore di Milano

    RECRUITING

    Milan, Italy

  • Ospedale Pediatrico Meyer Firenze

    RECRUITING

    Florence, Italy

  • UMC Utrecht

    RECRUITING

    Utrecht, Netherlands

  • University Hospital Essen

    RECRUITING

    Essen, Germany

  • University Hospital La Paz

    RECRUITING

    Madrid, Spain

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