Actively Recruiting
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial
Led by University of Alabama at Birmingham · Updated on 2025-12-29
188
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether early developmental intervention (EDI) using finger puppets to encourage joint attention and interactive communication in preterm infants can improve developmental outcomes. The study compares this approach plus routine EDI care including Bookworm reading training against routine EDI care alone. The trial focuses on infants born before 34 weeks' gestation and aims to increase developmental scores at 12 months corrected age. Participants are divided into two groups: one group receives finger puppets and extra training on infant-parent interaction and communication, along with routine EDI care and Bookworm reading training. The other group receives only routine EDI care with Bookworm training. This is a randomized, double-blind trial assessing behavioral interventions delivered by caregivers. Throughout the study, infants' development will be assessed using the Ages and Stages Questionnaire (ASQ) at 12 months corrected age as the primary outcome. Secondary outcomes include ASQ scores at 24 months, neurodevelopmental impairment measures, cognitive, language, and motor scores at 24 months, depression scale at 6 months, and other developmental screening tools. The study involves regular monitoring of infant progress and caregiver training, with participation lasting up to 24 months corrected age.
CONDITIONS
Brief Title
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Inborn at University of Alabama at Birmingham, delivered before 34 weeks' gestation
- Postmenstrual age between 32 and 39 weeks
- Off sedatives
- Off invasive respiratory support
You will not qualify if you...
- Presence of a major malformation
- Known syndrome diagnosis
- Currently enrolled in another clinical trial targeting neurodevelopmental outcomes as a primary outcome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months corrected age
Participants receive caregiver-implemented early developmental intervention using finger puppets or routine early developmental intervention care including Bookworm training. This involves training focused on infant-parent interaction and developmentally appropriate infant communication.
Regular visits for training and assessments during the intervention period
Duration - Up to 24 months corrected age
Participants are assessed for developmental outcomes such as ASQ scores and neurodevelopmental impairment up to 24 months corrected age.
1 to 2 visits depending on assessment schedules
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
Research Team
T
Tamaryn H Garcia
K
Kimberly M Armstead
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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