Observing the development of infants with cerebral palsy

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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

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• Smartphone gait checks for kids with unilateral spastic CP

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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.