Natural History of Cerebral Palsy Prospective Study

Cerebral Palsy Clinical Trial

Official title:

Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576948
• Other study ID #: 2022-0189
• Status: Recruiting
• Start date: September 8, 2022
• Est. completion date: September 8, 2026

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Karen L Harpster, PhD
• Phone: 513-803-3604
• Email: karen.harpster[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 8, 2026
• Est. primary completion date: September 8, 2025
• Gender: All
• Age group: 3 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Cerebral Palsy Alliance

Country where clinical trial is conducted

United States, 

Outcome

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