Early intervention program for infants at risk of cerebral palsy
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 8 Weeks to 20 Weeks |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Charlottenlund, København City) |
| Trial ID | NCT04250454 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe genetic abnormalities, heart problems, metabolic diseases, or those still hospitalized may not benefit from this study.
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 performed: Other studies have shown promise in early interventions for cerebral palsy, but this specific approach is novel.
Eligibility criteria
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 this trial is running
Charlottenlund, København City
- Elsass Foundation — Charlottenlund, København City, Denmark (Recruiting)
Study contacts
- Study coordinator: Jens Nielsen, Professor
- Email: jbnielsen@sund.ku.dk
- Phone: +4528757450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.