Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants

Not Applicable

Recruiting

• Conditions: Infant, Premature, Diseases; Child Development; Infant Development
• Interventions: Behavioral: Finger puppet; Behavioral: Bookworm reading intervention training and routine EDI care.

• Registration Number: NCT06335524
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Study Start: 2024-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caregiver-implemented early developmental intervention (EDI) using finger puppets	Bookworm reading intervention training and routine EDI care.	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.
Caregiver-implemented early developmental intervention (EDI) using finger puppets	Finger puppet	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.
Routine EDI care including Bookworm training	Bookworm reading intervention training and routine EDI care.	All study participants will receive Bookworm reading intervention training and routine EDI care.

Primary Outcome Measures

Name	Time	Method
ASQ-3 scores	12 months corrected age	Ages and Stages Questionnaires 3rd Edition

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States