Natural History of Cerebral Palsy Prospective Study

NCT05576948 | Recruiting DMC

• 1 other identifier: 2022-0189
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (14)

• Change in Motor skills

  Peabody: Gross and Fine motor skills

  3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

• 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)

• Change in Cognitive skills

  Bayley Scales of Infant and Toddler Development

  6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

• Change in Neurologic assessment

  Hammersmith Infant Neurological Examination

  3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

• Change in Musculoskeletal assessment

  Modified Tardieu Scale

  3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

• Change in Musculoskeletal assessment

  Australian Spasticity Assessment Scale

  9 months, 12 months, 18 months, 24 months (corrected age)

• Change in Musculoskeletal assessment

  Hip X-ray

  18 months, 24 months corrected age

• Change in Vision

  Previas

  6 months, 9 months, 12 months, 18 months, 24 months (corrected age)

• Vision

  Ricci

  3 months corrected age

• Change in Sleep

  Sleep disturbances Scale for Children

  9 months, 12 months, 18 months, 24 months (corrected age)

• Change in Feeding skills

  Dysphagia Disorder Survey

  12 months, 18 months, 24 months (corrected age)

• Change in Self Care

  Pediatric Evaluation of Disability Inventory Computerized Assessment Test

  6 months, 12 months, 18 months, 24 months (corrected age)

• Change in Adaptive Behavior

  Infant Toddler Social Emotional Assessment

  12 months, 18 months, 24 months (corrected age)

• Change in Parent Well Being

  Depression, Anxiety and Stress Scale

  12 months, 18 months, 24 months (corrected age)

Study Arms (1)

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.

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants with or at high-risk for CP

You may qualify if:

• 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:
• 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.
• Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
• 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

You may not qualify if:

• Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
• Infants with other disability diagnoses e.g. Down Syndrome

Sponsors & Collaborators

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

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Karen L Harpster, PhD

CONTACT

513-803-3604; karen.harpster@cchmc.org

Kelly Greve, PhD

CONTACT

(513) 636-3605; kelly.greve@cchmc.org

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 13, 2022
• Study Start: September 8, 2022
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 8, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)