Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
Purpose
This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.
Conditions
- Child Development
- Infant Development
- Infant, Premature, Diseases
Eligibility
- Eligible Ages
- Between 1 Week and 17 Weeks
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.
Exclusion Criteria
- a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Caregiver-implemented early developmental intervention (EDI) using finger puppets |
Caregivers of infants in the intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training. |
|
Active Comparator Routine EDI care including Bookworm training |
All study participants will receive Bookworm reading intervention training and routine EDI care. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35249
Birmingham, Alabama 35249
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham