Clinical trial Recruiting at 1 site Interventional Ages 8 Weeks to 20 Weeks

Early intervention program for infants at risk of cerebral palsy

Official title: Protocol of a Two-group Open-label Randomized Clinical Trial With Blinded Assessment for Prevention of Contractures in Infants With High Risk of Cerebral Palsy.

Run by University of Copenhagen · NCT04250454 · Data updated 2026-11-12

This study is testing an early intervention program for infants at risk of cerebral palsy to see if it can help improve their muscle growth and mobility compared to standard care.

Quick facts

Study typeInterventional
Ages8 Weeks to 20 Weeks
SexAll
Enrollment36 (estimated)
SponsorUniversity of Copenhagen
Academic / other
Locations1 site (Charlottenlund, København City)
StatusRecruiting
StartedMay 20, 2021
Main results expectedDecember 2025
Study endsDecember 2029
Registry record updatedMay 9, 2024
Trial IDNCT04250454 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants younger than 17 weeks with suspected brain lesions and a high risk of developing cerebral palsy.

Probably not a fit

Patients with severe genetic abnormalities, heart problems, metabolic diseases, or those still hospitalized may not benefit from this study.

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

What this trial studies

This study aims to evaluate the effectiveness of an early intervention program called CONTRACT in promoting muscle growth and mobility in infants at high risk of developing cerebral palsy (CP). The intervention targets infants under 17 weeks of corrected age who show signs of brain lesions, with the goal of preventing contractures that can limit mobility and functional abilities. By comparing the outcomes of the CONTRACT program to standard care, the study seeks to establish a proactive approach to enhance motor and cognitive development in these vulnerable infants.

Why it matters

Potential benefit: If successful, this intervention could significantly improve mobility and overall development in infants at risk of cerebral palsy.

How similar studies have gone: Other studies have shown promise in early interventions for cerebral palsy, but this specific approach is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Infants younger than 17 weeks CA with suspicion of brain lesion determined from a medical assessment, by MRI or ultrasound scan or abcent fidgety movements (FM) determined as part of General Movement Asessement (GMA) will be included. The brain lesion should be rated severe enough by the clinician to have informed the parents of the associated risk of CP.

Exclusion Criteria:

* Infants otherwise eligible but with severe genetic abnormalties, severe heart problems, metabolic diseases, or still hospitalized will not be selected for the study.

Where it's running

  • Elsass Foundation
    Charlottenlund, København City, Denmark
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.