Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

NCT ID: NCT06335524

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Child Development Infant Development Infant, Premature, Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Finger puppet

Intervention Type 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.

Intervention Type BEHAVIORAL

Routine EDI care including Bookworm training.

Routine EDI care including Bookworm training

All study participants will receive Bookworm reading intervention training and routine EDI care.

Group Type ACTIVE_COMPARATOR

Bookworm reading intervention training and routine EDI care.

Intervention Type BEHAVIORAL

Routine EDI care including Bookworm training.

Interventions

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Finger puppet

The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.

Intervention Type BEHAVIORAL

Bookworm reading intervention training and routine EDI care.

Routine EDI care including Bookworm training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Week

Maximum Eligible Age

17 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Colm Travers

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colm P Travers

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tamaryn H Garcia

Role: CONTACT

Phone: 2059344680

Email: [email protected]

Kimberly M Armstead

Role: CONTACT

Phone: 2059340095

Email: [email protected]

Facility Contacts

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Colm P Travers, MD

Role: primary

Jillian Hamilton, PhD

Role: backup

Other Identifiers

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UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300012718

Identifier Type: -

Identifier Source: org_study_id