N/A
N=12
Movement-based Infant Intervention
Infant Development · Infant,Premature · Infant, Very Low Birth Weight · Infant, Small for Gestational Age · Infant Conditions
Bottom Line
View on ClinicalTrials.gov: NCT03082313 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Movement Rate — 1278 average leg movements per hour awake
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Movement Intervention (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Movement Rate |
1278 | — |
Summary
The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay. The intervention promotes movement experience from 3 months to sitting onset.
Eligibility Criteria
Inclusion Criteria
- Infants will be 3 months of adjusted age at the first visit, +/- 10 days. Infants will be defined as at risk if they qualify for high risk infant follow up care as defined by California Children's Services.
Exclusion Criteria
- Infants with congenital malformations of the legs will be excluded.
Data sourced from ClinicalTrials.gov (NCT03082313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.