Actively Recruiting
The Ontogeny of Fidgety Movements in Infants At High-Risk of Cerebral Palsy
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2025-02-13
350
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
N
Northwestern University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying infants with and without medical complexities to improve early detection of neurodevelopmental impairments, especially cerebral palsy (CP). The study aims to find the best time to use the Prechtl General Movement Assessment (GMA) to predict developmental outcomes by age two. The study plans to enroll 350 infants, including 100 healthy term-born babies and 250 at risk for CP, and involves multiple research teams across several institutions. Families will use the Baby Moves app to record videos of their infants at specific ages (10, 12, 14, 16, 18, and 20 weeks corrected age). These videos are reviewed by trained assessors using the Prechtl GMA method to identify movement patterns. If an infant's movements are considered high risk, families receive a follow-up virtual visit with developmental assessments. Infants may also be referred to early intervention services. Data is securely stored in REDCap databases managed across participating sites. Participants will be followed for five years, with developmental assessments at one and two years of age, including standardized tests like the Bayley Scales and questionnaires about quality of life and behavior. Families will complete surveys about the Baby Moves app and participate in phone follow-ups. Researchers will measure fidgety movements at 4 months and neurodevelopmental outcomes at 2 years, tracking diagnoses and developmental progress. The study collects comprehensive medical and developmental data to improve early detection methods.
CONDITIONS
Brief Title
Families Filming Infants Learning Movement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born full-term with typical development and birthweight over 2500g
- Infants with bronchopulmonary dysplasia, defined as preterm birth before 33 weeks and requiring supplemental oxygen beyond 36 weeks
- Infants with neonatal encephalopathy who required hypothermic cooling treatment
- Infants born before 36 weeks gestational age
- Infants from multiple gestation pregnancies
- Infants diagnosed with Trisomy 21
- Infants diagnosed with spinal muscular atrophy (SMA) prenatally, via newborn screening, or before 10 weeks corrected age
- Infants less than 10 weeks corrected age at enrollment
You will not qualify if you...
- Children enrolled in Department of Children and Family Services (DCFS) custody
- Parent or infant guardian does not have a smartphone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants complete electronic consent and enrollment online with remote support as needed.
Duration - From enrollment up to 20 weeks corrected age
Participants use the Baby Moves app to film and upload videos of infant movements at specified ages. Videos are reviewed by experts to assess movement patterns.
Reminders sent at 10, 12, 14, 16, 18, and 20 weeks of corrected age for video uploads via the app.
Duration - Up to 5 years
Families of infants identified as high-risk receive virtual developmental assessments and referrals, while all infants are followed for up to five years with data collected through surveys and clinical visits depending on risk group.
Virtual developmental assessments for high-risk infants; surveys at 12 and 24 months for all; follow-up clinic visits for high-risk infants as per routine care.
Trial Site Locations
Total: 1 location
1
Feinberg School of Physical Therapy and Human Movement Sciences
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
I
Imani Mann, B.S.
C
Colleen Peyton, DPT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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