Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05576948

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Cerebral Palsy

Study ID

NCT05576948

Start date

Sep 8, 2022

Status verified date

Sep, 2025

Completion date

Sep 8, 2027

Anticipated

Primary completion date

Sep 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with or at high risk of CP

Infants with a diagnosis of CP OR at high risk of CP as per the international Clinical Practice Guideline for early diagnosis of CP. In order to develop prognostic curves for motor function a minimum of 3 data points are required per participant. For this reason infants will be included if they are 12 months or younger (corrected age) at the time of enrolment.

Primary outcome measure

  • Change in Motor skills [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) ]
  • Change in Speech and Language skills [ Time Frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) ]
  • Change in Cognitive skills [ Time Frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) ]
  • Change in Neurologic assessment [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) ]
  • Change in Musculoskeletal assessment [ Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) ]
  • Change in Musculoskeletal assessment [ Time Frame: 9 months, 12 months, 18 months, 24 months (corrected age) ]
  • Change in Musculoskeletal assessment [ Time Frame: 18 months, 24 months corrected age ]
  • Change in Vision [ Time Frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) ]
  • Vision [ Time Frame: 3 months corrected age ]
  • Change in Sleep [ Time Frame: 9 months, 12 months, 18 months, 24 months (corrected age) ]
  • Change in Feeding skills [ Time Frame: 12 months, 18 months, 24 months (corrected age) ]
  • Change in Self Care [ Time Frame: 6 months, 12 months, 18 months, 24 months (corrected age) ]
  • Change in Adaptive Behavior [ Time Frame: 12 months, 18 months, 24 months (corrected age) ]
  • Change in Parent Well Being [ Time Frame: 12 months, 18 months, 24 months (corrected age) ]

Central Contacts and Locations

Central contacts

Karen L Harpster, PhD

513-803-3604karen.harpster@cchmc.org

Kelly Greve, PhD

(513) 636-3605kelly.greve@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Karen L Harpster, PhD, OTR/L

513-803-3604karen.harpster@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-09-25.