Observing the development of infants with cerebral palsy
Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study
Children's Hospital Medical Center, Cincinnati · NCT05576948
This study looks at how infants with or at risk for cerebral palsy grow and develop in their first two years to help doctors and therapists better support them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 3 Months to 24 Months |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05576948 on ClinicalTrials.gov |
What this trial studies
This study aims to describe the early natural history of cerebral palsy (CP) by mapping the development of infants diagnosed with or at high risk for CP over their first two years of life. Infants will be assessed at regular intervals up to 24 months, focusing on various aspects of childhood development to create comprehensive developmental trajectories. The findings will enhance the understanding of CP development, aiding clinicians and therapists in providing accurate prognostic information and targeted early interventions. This study is part of a larger multi-site international initiative.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under 12 months with a diagnosis of cerebral palsy or those identified as at high risk for developing CP.
Not a fit: Patients who do not meet the eligibility criteria, such as those over 12 months or without a diagnosis or risk factors for CP, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early interventions and better outcomes for infants with cerebral palsy.
How similar studies have performed: Other studies have shown success in understanding the natural history of cerebral palsy, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months.
* Infants at high risk of CP as defined by any two (any combination) of the following:
1. Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids.
2. Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
3. Hammersmith Infant Neurological Exam (HINE) scores \<57 @ 3months or \<60 @ 6months or \<63 @9 months
Infants will also be included if they meet BOTH of the following criteria (even if infants have a HINE score greater than the cut off scores stated above:
i. Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) or cranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry
Exclusion Criteria:
* Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
* Infants with other disability diagnoses e.g. Down Syndrome
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Karen L Harpster, PhD
- Email: karen.harpster@cchmc.org
- Phone: 513-803-3604
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.
Conditions: Cerebral Palsy