Families Filming Infants Learning Movement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-20
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants.
Eligibility criteria
Qualifiers
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
Disqualifiers
Children who are enrolled in DCFS custody
Parent or infant guardian does not have a smartphone
Trial design
Treatments tested in this trial
- Observational
Treatment groups
350 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
Northwestern University
Sponsor institution
Northwestern University
Collaborator
IRCCS Fondazione Stella Maris
Collaborator
University of Melbourne
Collaborator
University of Sydney
Collaborator
Source ClinicalTrials.gov