NCT05576948 · Children's Hospital Medical Center, Cincinnati
Natural History of Cerebral Palsy Prospective Study
What this study is about
The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.
View original scientific description
The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.
Primary outcome measures
Change in Motor skills
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Peabody: Gross and Fine motor skills
Change in Speech and Language skills
Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Bayley Scales of Infant and Toddler Development
Change in Cognitive skills
Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Bayley Scales of Infant and Toddler Development
Change in Neurologic assessment
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Hammersmith Infant Neurological Examination
Change in Musculoskeletal assessment
Time frame: 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Modified Tardieu Scale
Change in Musculoskeletal assessment
Time frame: 9 months, 12 months, 18 months, 24 months (corrected age)
Australian Spasticity Assessment Scale
Change in Musculoskeletal assessment
Time frame: 18 months, 24 months corrected age
Hip X-ray
Change in Vision
Time frame: 6 months, 9 months, 12 months, 18 months, 24 months (corrected age)
Previas
Vision
Time frame: 3 months corrected age
Ricci
Change in Sleep
Time frame: 9 months, 12 months, 18 months, 24 months (corrected age)
Sleep disturbances Scale for Children
Change in Feeding skills
Time frame: 12 months, 18 months, 24 months (corrected age)
Dysphagia Disorder Survey
Change in Self Care
Time frame: 6 months, 12 months, 18 months, 24 months (corrected age)
Pediatric Evaluation of Disability Inventory Computerized Assessment Test
Change in Adaptive Behavior
Time frame: 12 months, 18 months, 24 months (corrected age)
Infant Toddler Social Emotional Assessment
Change in Parent Well Being
Time frame: 12 months, 18 months, 24 months (corrected age)
Depression, Anxiety and Stress Scale
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Cincinnati, Ohio
Collaborators
Cerebral Palsy Alliance
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2025 · Source of record for eligibility and locations