Observing how infants learn to move
The Ontogeny of Fidgety Movements in Infants At High-Risk of Cerebral Palsy
This study is testing how babies move to see if it can help find signs of cerebral palsy earlier, and it's for infants who are healthy as well as those at risk for the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 10 Weeks to 20 Weeks |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06278961 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the early detection of neurodevelopmental impairments, particularly cerebral palsy (CP), by assessing the timing of the Prechtl General Movement Assessment (GMA) in infants. The study will recruit a total of 350 infants, including 100 healthy term-born infants and 250 at risk for CP, to evaluate their movement patterns using the Baby Moves app. Data will be collected across multiple research institutions, with a focus on standardizing the methodology and ensuring comprehensive data management through REDCap databases. Families will be recruited through various channels, including electronic medical records and social media, with an emphasis on minimizing in-person contact through electronic consent.
Who should consider this trial
Good fit: Ideal candidates include full-term infants with typical development or those at risk for developing cerebral palsy due to various medical conditions.
Not a fit: Infants who are in DCFS custody or whose guardians do not have access to a smartphone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of neurodevelopmental disorders in infants, allowing for timely interventions.
How similar studies have performed: Other studies have shown promise in using observational assessments for early detection of neurodevelopmental issues, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants born full-term with typical development, bithweight \>2500g * Infants with a history of brochopulmonary dysplasia, defined as having a preterm birth (\<33 weeks gestational age) and requiring supplemental oxygen beyond 36 weeks gestational age * Infants with neonatal encephalopathy, who required hypothermic cooling treatment * Infants born \<36 weeks gestational age * Infants born in a multiple gestation pregnancy * Infants with a diagnosis of Trisomy 21 * Infants born and diagnosed with SMA prenatally, via newborn screening assessment or prior to 10 weeks corrected age * Infants are less than 10 weeks corrected age at time of enrollment Exclusion Criteria: * Children who are enrolled in DCFS custody * Parent or infant guardian does not have a smartphone
Where this trial is running
Chicago, Illinois
- Feinberg School of Physical Therapy and Human Movement Sciences — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Imani Mann, B.S.
- Email: imani.mann@northwestern.edu
- Phone: 630-248-3514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.