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Early intervention may ease cerebral palsy in infants

NCT ID NCT06180291

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether starting a personalized home therapy program early (before age 2) can improve motor skills in babies at high risk for cerebral palsy. Researchers will compare children who receive this early program with those who get standard care. The goal is to see if early treatment helps reduce the long-term impact of the condition.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 66 people

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

Started

Mar 2025

Expected to finish

Sep 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.

Ages

Up to 3 months

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: * New born presenting on transfontanellar ultrasound and confirmed on brain MRI (magnetic resonance imaging) at least one of the following brain lesions at high risk of cerebral palsy : * Stage 3 intraventricular hemorrhage, requiring at least 2 subtractive lumbar punctures and/or the establishment of a ventriculoperitoneal bypass * Stage 4 intraventricular hemorrhage * Periventricular leukomalacia : extensive unilateral or bilateral * Sequelae of perinatal anoxo-ischemic encephalopathy * Extensive neonatal stroke * Less than 3 months old (corrected age in case of prematurity) * Hospitalized in neonatology or hospitalized in pediatric intensive care unit or within two months following return home (follow-up visit after initial hospitalization) * Affiliate to social security * Parental or legal representative consent to participate in the study (free and informed written consent) Exclusion Criteria: * Children who have had an Antenatal Diagnosis of a pathology causing fear of the onset of developmental delay * Children presenting with a congenital pathology with neonatal revelation, whether of metabolic, genetic or malformative origin * Palliative care offered by the neonatology team (LATA: Limitation and Discontinuation of Active Therapeutics) * Children participating simultaneously in another screening and early care program (excluding the COCON program (Soins préCOces et COordonnés du Nouveau-né vulnérable))

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Conditions

The condition(s) this trial relates to.

cerebral palsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebral palsy

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. 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

  • CH de Annecy

    RECRUITING

    Annecy, 74370, France

  • Service de Réanimation Néonatale, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

    RECRUITING

    Lyon, 69317, France

  • Service de Réanimation et médecine néonatale

    RECRUITING

    Chambéry, 73011, France

  • Service de néonatologie et de réanimation néonatale, CHU Saint-ELOI

    RECRUITING

    Montpellier, 34295, France

  • Service de néonatologie et de réanimation néonatale, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

    RECRUITING

    Lyon, 69677, France

  • Service de néonatologie et de réanimation néonatale, Hôpital Universitaire Carémeau

    RECRUITING

    Nîmes, 30029, France

  • Service de néonatologie, Hôpital des enfants

    RECRUITING

    Toulouse, 31300, France

  • Service de réanimation pédiatrique, Hôpital des enfants

    RECRUITING

    Toulouse, 31059, France

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