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NOT YET RECRUITING
NCT07820462
NA

NICU-to-Home Dyadic Support for Very Preterm Infants and Families

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

This feasibility study will evaluate delivery of the Supporting Play Exploration and Early Development Intervention after neonatal intensive care unit discharge for very preterm infants and their families. Parent-preterm infant dyads will be assigned to homebased SPEEDI, telehealth SPEEDI, or a control group. SPEEDI is an early developmental intervention focused on supporting parent confidence, interpretation of infant behavioral cues, and parent-infant relationship building through developmentally appropriate play. The study will assess feasibility of initiating SPEEDI 1 to 5 days after NICU discharge, including recruitment, retention, session attendance, activity log completion, intervention adherence, and delivery differences between homebased and telehealth SPEEDI. Family experiences and provider perspectives on strengths and barriers to SPEEDI implementation will also be evaluated.

Official title: Providing NICU-to-Home Dyadic Support for Very Preterm Infants and Their Families: A Feasibility Study

Key Details

Gender

All

Age Range

0 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11-16

Completion Date

2028-12-01

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

BEHAVIORAL

Homebased SPEEDI

The SPEEDI intervention is an early developmental intervention grounded in positive parent-infant relationship building. Homebased SPEEDI will be delivered in the family home over 10 sessions across 15 weeks after baseline. The intervention supports parents in interpreting infant behavioral cues and stress signs, building parent confidence, and engaging the infant in developmentally appropriate therapeutic play.

BEHAVIORAL

Telehealth SPEEDI

Telehealth SPEEDI will deliver the SPEEDI intervention remotely over 10 sessions across 15 weeks after baseline. Sessions will support parents in interpreting infant cues, increasing confidence, and engaging the infant in developmentally appropriate play using telehealth-based coaching.

Locations (2)

Masonic Institute for the Developing Brain

Minneapolis, Minnesota, United States

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, United States