Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06335524
Status
Recruiting
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Conditions

  • Child Development
  • Infant Development
  • Infant, Premature, Diseases

Eligibility Criteria

Sex
ALL
Age
1 Week - 17 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Finger puppet — BEHAVIORAL
    The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.
  • Bookworm reading intervention training and routine EDI care. — BEHAVIORAL
    Routine EDI care including Bookworm training.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

ASQ-3 scores [ Time Frame: 12 months corrected age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249
Colm P Travers, MD
[email protected]
2059344680
Jillian Hamilton, PhD
[email protected]
2059344680
Waldemar A Carlo, MD (SUB_INVESTIGATOR)

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