Clinical trial NCT05576948: Natural History of Cerebral Palsy Prospective Study
Official title: Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Cerebral Palsy Alliance
First posted: 2022-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants with or at high-risk for CP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Motor skills
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
measure: Change in Speech and Language skills
timeFrame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
measure: Change in Cognitive skills
timeFrame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
measure: Change in Neurologic assessment
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
measure: Change in Musculoskeletal assessment
timeFrame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
measure: Change in Musculoskeletal assessment
timeFrame: 9 months, 12 months, 18 months, 24 months (corrected age)
measure: Change in Musculoskeletal assessment
timeFrame: 18 months, 24 months corrected age
measure: Change in Vision
timeFrame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
measure: Vision
timeFrame: 3 months corrected age
measure: Change in Sleep
timeFrame: 9 months, 12 months, 18 months, 24 months (corrected age)
measure: Change in Feeding skills
timeFrame: 12 months, 18 months, 24 months (corrected age)
measure: Change in Self Care
timeFrame: 6 months, 12 months, 18 months, 24 months (corrected age)
measure: Change in Adaptive Behavior
timeFrame: 12 months, 18 months, 24 months (corrected age)
measure: Change in Parent Well Being
timeFrame: 12 months, 18 months, 24 months (corrected age)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: