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 type | Interventional |
|---|---|
| Ages | 8 Weeks to 20 Weeks |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Charlottenlund, København City) |
| Status | Recruiting |
| Started | May 20, 2021 |
| Main results expected | December 2025 |
| Study ends | December 2029 |
| Registry record updated | May 9, 2024 |
| Trial ID | NCT04250454 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
- Study coordinator: Jens Nielsen, Professor
- Email: jbnielsen@sund.ku.dk
- Phone: +4528757450
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
This study tests whether Sensory Integration Therapy helps improve gross motor function more than standard physical therapy in children aged 4–10 with mixed cerebral palsy.
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Turkish version of ABILHAND-Kids Young CP: translation, adaptation, and reliability
A Turkish version of the ABILHAND-Kids Young CP questionnaire is being created and tested to see if it reliably measures manual ability in 2-to-7-year-olds with cerebral palsy, based on parent reports.
-
Multisite upper limb surgery in children with unilateral cerebral palsy
This study looks at whether individualized multisite upper limb surgery helps improve hand function in kids with hemiplegic cerebral palsy, using each child as their own control before and after surgery.
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Spinal Stimulation During Walking to See If Spasticity Lessens in Cerebral Palsy
This study tests whether walking with non-invasive spinal stimulation reduces leg muscle tightness and improves walking in children and young adults with cerebral palsy.
-
Combined leg nerve blocks for kids with cerebral palsy after surgery
This study tests whether adding two nerve blocks to standard anesthesia helps control pain in children with cerebral palsy after lower limb surgery.
-
Smartphone gait checks for kids with unilateral spastic CP
This study tests whether a phone’s accelerometer can reliably measure walking in children with unilateral spastic cerebral palsy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.