Natural History of Cerebral Palsy Prospective Study

Recruiting

• Conditions: Cerebral Palsy

• Registration Number: NCT05576948
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-09-08
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-09
• Study First Posted: 2022-10-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18
• Primary Completion: 2025-09-08
• Study Completion: 2026-09-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Musculoskeletal assessment	18 months, 24 months corrected age	Hip X-ray
Change in Speech and Language skills	6 months, 9 months, 12 months, 18 months, 24 months (corrected age)	Bayley Scales of Infant and Toddler Development
Change in Cognitive skills	6 months, 9 months, 12 months, 18 months, 24 months (corrected age)	Bayley Scales of Infant and Toddler Development
Change in Neurologic assessment	3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)	Hammersmith Infant Neurological Examination
Change in Vision	6 months, 9 months, 12 months, 18 months, 24 months (corrected age)	Previas
Vision	3 months corrected age	Ricci
Change in Self Care	6 months, 12 months, 18 months, 24 months (corrected age)	Pediatric Evaluation of Disability Inventory Computerized Assessment Test
Change in Motor skills	3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)	Peabody: Gross and Fine motor skills
Change in Sleep	9 months, 12 months, 18 months, 24 months (corrected age)	Sleep disturbances Scale for Children
Change in Feeding skills	12 months, 18 months, 24 months (corrected age)	Dysphagia Disorder Survey
Change in Adaptive Behavior	12 months, 18 months, 24 months (corrected age)	Infant Toddler Social Emotional Assessment
Change in Parent Well Being	12 months, 18 months, 24 months (corrected age)	Depression, Anxiety and Stress Scale

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States