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Recruiting NCT05576948

Natural History of Cerebral Palsy Prospective Study

— Observational Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cerebral Palsy. Basic parameters: 3 months — 24 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Change in Motor skills [Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
  • Change in Speech and Language skills [Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
  • Change in Cognitive skills [Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
  • Change in Neurologic assessment [Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
  • Change in Musculoskeletal assessment [Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
  • Change in Musculoskeletal assessment [Time frame: 9 months, 12 months, 18 months, 24 months (corrected age)]
  • Change in Musculoskeletal assessment [Time frame: 18 months, 24 months corrected age]
  • Change in Vision [Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)]
  • Vision [Time frame: 3 months corrected age]
  • Change in Sleep [Time frame: 9 months, 12 months, 18 months, 24 months (corrected age)]

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:
  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Ecologic or community

Study locations

United States · 1 center
  • Cincinnati Children's Hospital Medical Center — Cincinnati

Identifiers

NCT: NCT05576948 · 2022-0189

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗