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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05576948
Other study ID # 2022-0189
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.


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Study Design


Related Conditions & MeSH terms


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)
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