N/A
N=20
A Novel Parent Education Program for Early Intervention
Preterm Infant · Full-term Infant
Bottom Line
View on ClinicalTrials.gov: NCT04266717 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Alberta Infant Motor Scale - Change in Total Percentile Score — 10; 0 change in percentile rank — p=0.016
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Baby Play Intervention (Behavioral); Milestone Education (Behavioral)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Delaware
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alberta Infant Motor Scale - Change in Total Percentile Score |
10; 0 | 0.016 sig |
Summary
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. Because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive early intervention until they are older and their delays are more pronounced. This project aims to address the need for an effective, affordable, novel early intervention model for the first months of life for preterm infants.
Eligibility Criteria
Inclusion Criteria
- Infant meeting the age criteria
- Access to the internet
- Residence within driving distance of the University of Delaware
- Parental ability to read and communicate in English
Exclusion Criteria
- Genetic diagnosis
- Progressive diagnosis such as spinal muscular atrophy
- Medical or movement restrictions that would interfere with participation in the study activities
Data sourced from ClinicalTrials.gov (NCT04266717). 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.