Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT06335524

Conditions

Child Development

Infant Development

Infant, Premature, Diseases

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Finger puppet

Bookworm reading intervention training and routine EDI care.

Study Details

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.

Conditions

Child Development

Infant Development

Infant, Premature, Diseases

Study ID

NCT06335524

Start date

Nov 1, 2024

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Finger puppet

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.

Routine EDI care including Bookworm training.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Tamaryn H Garcia

2059344680thgarcia@uabmc.edu

Kimberly M Armstead

2059340095karmstead@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Colm P Travers, MD

2059344680cptravers@uabmc.edu

Jillian Hamilton, PhD

2059344680jchamilton@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-29.