Natural History of Cerebral Palsy Prospective Study

Last updated: September 22, 2025
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT05576948
2022-0189
  • Ages 3-24
  • All Genders

Study Summary

The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infants will be included if they have a diagnosis of CP or "at high risk of CP" andunder 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 ormore 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 MovementAssessment (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 (evenif infants have a HINE score greater than the cut off scores stated above: i. Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) orcranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry

Exclusion

Exclusion Criteria:

  • Infants with progressive or neurodegenerative disorders or genetic disorders notassociated with CP

  • Infants with other disability diagnoses e.g. Down Syndrome

Study Design

Total Participants: 100
Study Start date:
September 08, 2022
Estimated Completion Date:
September 08, 2027

Study Description

This study aims to describe the early natural history of cerebral palsy (CP) by mapping the development of infants with, or at-risk of CP, over the first two years of life. Infants will be assessed at regular intervals up to 24 months of age, across a variety of childhood development to provide the first comprehensive developmental trajectories of this group. In doing so, it will contribute to the existing knowledge of CP development to assist clinicians and therapists with accurate information on prognosis and provide targeted interventions early and at the 'just-right' challenge. Where indicated, individual participants' results from this study will be used to inform their therapy. This study is intended to form part of a larger multi-site international study.

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Active - Recruiting

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