Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
- Conditions
- Infant, Premature, DiseasesChild DevelopmentInfant Development
- Registration Number
- NCT06335524
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 188
- inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.
- a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method ASQ-3 scores 12 months corrected age Ages and Stages Questionnaires 3rd Edition
- Secondary Outcome Measures
Name Time Method Edinburgh Postnatal Depression Scale 6 months Maternal scores on Edinburgh Postnatal Depression Scale
ASQ scores below -2SD 24 months corrected age Ages and Stages Questionnaires 3rd Edition
ASQ-3 scores 24 months corrected age Ages and Stages Questionnaires 3rd Edition
Severe neurodevelopmental impairment 24 months corrected age Composite outcome based on BSID scores, GMFCS, Vision, Hearing
Language Composite Score on BSID-IV 24 months corrected age Bayley's Scales of Infant Development IV language composite score
ASQ scores below -1SD 24 months corrected age Ages and Stages Questionnaires 3rd Edition
ASQ-SE2 scores 24 months corrected age Ages and Stages Questionnaires 3rd Edition
Moderate or severe neurodevelopmental impairment 24 months corrected age Composite outcome based on BSID-IV scores, GMFCS, Vision, Hearing
Cognitive Composite Score on BSID-IV 24 months corrected age Bayley's Scales of Infant Development IV cognitive composite score
Motor Composite Score on BSID-IV 24 months corrected age Bayley's Scales of Infant Development IV motor composite score
MCHAT score 24 months corrected age Modified Checklist for Autism in Toddlers
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United StatesColm P Travers, MDContact205-934-4680ctravers@peds.uab.eduJillian Hamilton, PhDContact2059344680jchamilton@uabmc.eduWaldemar A Carlo, MDSub Investigator