Natural History of Cerebral Palsy Prospective Study

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT05576948
Collaborator
Cerebral Palsy Alliance (Other)
100
1
48
2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study
    Actual Study Start Date :
    Sep 8, 2022
    Anticipated Primary Completion Date :
    Sep 8, 2025
    Anticipated Study Completion Date :
    Sep 8, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Motor skills [3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]

      Peabody: Gross and Fine motor skills

    2. 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

    3. Change in Cognitive skills [6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]

      Bayley Scales of Infant and Toddler Development

    4. Change in Neurologic assessment [3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]

      Hammersmith Infant Neurological Examination

    5. Change in Musculoskeletal assessment [3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]

      Modified Tardieu Scale

    6. Change in Musculoskeletal assessment [9 months, 12 months, 18 months, 24 months (corrected age)]

      Australian Spasticity Assessment Scale

    7. Change in Musculoskeletal assessment [18 months, 24 months corrected age]

      Hip X-ray

    8. Change in Vision [6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]

      Previas

    9. Vision [3 months corrected age]

      Ricci

    10. Change in Sleep [9 months, 12 months, 18 months, 24 months (corrected age)]

      Sleep disturbances Scale for Children

    11. Change in Feeding skills [12 months, 18 months, 24 months (corrected age)]

      Dysphagia Disorder Survey

    12. Change in Self Care [6 months, 12 months, 18 months, 24 months (corrected age)]

      Pediatric Evaluation of Disability Inventory Computerized Assessment Test

    13. Change in Adaptive Behavior [12 months, 18 months, 24 months (corrected age)]

      Infant Toddler Social Emotional Assessment

    14. Change in Parent Well Being [12 months, 18 months, 24 months (corrected age)]

      Depression, Anxiety and Stress Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 24 Months
    Sexes Eligible for Study:
    All
    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:

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati
    • Cerebral Palsy Alliance

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT05576948
    Other Study ID Numbers:
    • 2022-0189
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 13, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2022