Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants (IMPACT)

Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infant, Premature, Diseases; Child Development; Infant Development
• Intervention / Treatment: Behavioral: Finger puppet; Behavioral: Bookworm reading intervention training and routine EDI care.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamaryn H Garcia; Phone Number: 2059344680; Email: thgarcia@uabmc.edu
• Study Contact Backup: Name: Kimberly M Armstead; Phone Number: 2059340095; Email: karmstead@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Finger puppet; The intervention group will receive finger-puppets and additional training pertaining to infant parent interaction and developmentally appropriate infant communication training.; Behavioral: Bookworm reading intervention training and routine EDI care.; Routine EDI care including Bookworm training.
Active Comparator: Routine EDI care including Bookworm training; All study participants will receive Bookworm reading intervention training and routine EDI care.	Behavioral: Bookworm reading intervention training and routine EDI care.; Routine EDI care including Bookworm training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASQ-3 scores	Ages and Stages Questionnaires 3rd Edition	12 months corrected age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASQ-3 scores	Ages and Stages Questionnaires 3rd Edition	24 months corrected age
ASQ scores below -2SD	Ages and Stages Questionnaires 3rd Edition	12 months corrected age
ASQ scores below -2SD	Ages and Stages Questionnaires 3rd Edition	24 months corrected age
ASQ scores below -1SD	Ages and Stages Questionnaires 3rd Edition	12 months corrected age
ASQ scores below -1SD	Ages and Stages Questionnaires 3rd Edition	24 months corrected age
ASQ-SE2 scores	Ages and Stages Questionnaires 3rd Edition	12 months corrected age
ASQ-SE2 scores	Ages and Stages Questionnaires 3rd Edition	24 months corrected age
Severe neurodevelopmental impairment	Composite outcome based on BSID scores, GMFCS, Vision, Hearing	24 months corrected age
Moderate or severe neurodevelopmental impairment	Composite outcome based on BSID-IV scores, GMFCS, Vision, Hearing	24 months corrected age
Cognitive Composite Score on BSID-IV	Bayley's Scales of Infant Development IV cognitive composite score	24 months corrected age
Language Composite Score on BSID-IV	Bayley's Scales of Infant Development IV language composite score	24 months corrected age
Motor Composite Score on BSID-IV	Bayley's Scales of Infant Development IV motor composite score	24 months corrected age
Edinburgh Postnatal Depression Scale	Maternal scores on Edinburgh Postnatal Depression Scale	6 months
MCHAT score	Modified Checklist for Autism in Toddlers	24 months corrected age

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Colm P Travers, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases
• Other Study ID Numbers: IRB-300012718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No