NCT06335524

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Nov 2024Dec 2028

First Submitted

Initial submission to the registry

March 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

March 21, 2024

Last Update Submit

December 19, 2025

Conditions

Child DevelopmentInfant DevelopmentInfant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

  • ASQ-3 scores

    Ages and Stages Questionnaires 3rd Edition

    12 months corrected age

Secondary Outcomes (14)

  • ASQ-3 scores

    24 months corrected age

  • ASQ scores below -2SD

    12 months corrected age

  • ASQ scores below -2SD

    24 months corrected age

  • ASQ scores below -1SD

    12 months corrected age

  • ASQ scores below -1SD

    24 months corrected age

  • +9 more secondary outcomes

Study Arms (2)

Caregiver-implemented early developmental intervention (EDI) using finger puppets

EXPERIMENTAL

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.

Behavioral: Finger puppetBehavioral: Bookworm reading intervention training and routine EDI care.

Routine EDI care including Bookworm training

ACTIVE COMPARATOR

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

Behavioral: Bookworm reading intervention training and routine EDI care.

Interventions

Finger puppetBEHAVIORAL

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

Caregiver-implemented early developmental intervention (EDI) using finger puppets
Bookworm reading intervention training and routine EDI care.BEHAVIORAL

Routine EDI care including Bookworm training.

Caregiver-implemented early developmental intervention (EDI) using finger puppetsRoutine EDI care including Bookworm training

Eligibility Criteria

Age1 Week - 17 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.

You may not qualify if:

  • a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Colm P Travers

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamaryn H Garcia

CONTACT

2059344680thgarcia@uabmc.edu

Kimberly M Armstead

CONTACT

2059340095karmstead@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 28, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)