Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 188
- Locations
- 2
- Primary Endpoint
- ASQ-3 scores
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Week to 17 Weeks (Child)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Finger puppet (Behavioral)
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.
Intervention: Bookworm reading intervention training and routine EDI care. (Behavioral)
Routine EDI care including Bookworm training
All study participants will receive Bookworm reading intervention training and routine EDI care.
Intervention: Bookworm reading intervention training and routine EDI care. (Behavioral)
Outcomes
Primary Outcomes
ASQ-3 scores
Time Frame: 12 months corrected age
Ages and Stages Questionnaires 3rd Edition
Secondary Outcomes
- ASQ-3 scores(24 months corrected age)
- MCHAT score(24 months corrected age)
- Edinburgh Postnatal Depression Scale(6 months)
- ASQ scores below -2SD(24 months corrected age)
- Severe neurodevelopmental impairment(24 months corrected age)
- Language Composite Score on BSID-IV(24 months corrected age)
- ASQ scores below -1SD(24 months corrected age)
- ASQ-SE2 scores(24 months corrected age)
- Moderate or severe neurodevelopmental impairment(24 months corrected age)
- Cognitive Composite Score on BSID-IV(24 months corrected age)
- Motor Composite Score on BSID-IV(24 months corrected age)
- ASQ scores below -2SD(12 months corrected age)
- ASQ scores below -1SD(12 months corrected age)
- ASQ-SE2 scores(12 months corrected age)
Investigators
Colm Travers
Associate Professor
University of Alabama at Birmingham