Early diagnosis and intervention for cerebral palsy in infants
Multi-center Prospective Cohort Study CP-EDIT: Cerebral Palsy - Early Diagnosis and Intervention Trial
This study is testing if an early diagnosis and intervention program can help infants at risk of cerebral palsy do better than just receiving standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 3 Months to 12 Months |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT05835674 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of an early diagnosis and intervention program for infants at risk of cerebral palsy. The study will include 500 infants from both newborn and infant detectable risk pathways across four pediatric centers in Denmark. It will systematically collect data on the infants' responses to the early intervention program, which is designed to be added to standard care. The goal is to demonstrate that this combined approach leads to better outcomes compared to standard care alone.
Who should consider this trial
Good fit: Ideal candidates for this study are infants who are either preterm with specific risk factors or those showing early signs of motor development issues.
Not a fit: Patients who do not exhibit any detectable risk factors for cerebral palsy or have progressive neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and improved intervention strategies for infants at risk of cerebral palsy, potentially enhancing their motor and cognitive development.
How similar studies have performed: Previous studies have indicated that early intervention programs can positively influence outcomes for children with cerebral palsy, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Group A: 'Newborn-detectable risk-pathway' * Preterm birth with gestational age below 32 or birth weight below 1500 g and clinical concern * Moderate to severe brain injury (Papile grade 3 to 4 intraventricular haemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation at birth) or other significant neurological condition) * History (e.g. neonatal seizures, Extra Corporal Membrane Oxygenation, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (brain malformation, increased tone) * Parental concern and one of the factors above Group B: 'Infant detectable risk-pathway' * Inability to sit independently by age 9 months * Hand function asymmetry or crawl asymmetry * Inability to take weight through the plantar surface of the feet * History (as above) or neurological risk factors * Parental concern and one of the factors above Exclusion Criteria: * 1\) Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP, 2) Infants with other disability diagnoses e.g. Down Syndrome.
Where this trial is running
Aalborg and 3 other locations
- University Hospital Aalborg — Aalborg, Denmark (Recruiting)
- University Hospital Aarhus — Aarhus, Denmark (Recruiting)
- University Hospital Herlev — Herlev, Denmark (Recruiting)
- University Hospital Rigshospitalet, Dept. Paediatrics — Copenhagen, Østerbro, Denmark (Recruiting)
Study contacts
- Study coordinator: Christina E Hoei-Hansen
- Email: christina.hoei-hansen@regionh.dk
- Phone: +4535455095
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.