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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07820462
Status
Not Yet Recruiting

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Conditions

  • Infant Development
  • Neonatal Intensive Care Unit
  • Preterm Birth
  • Very Preterm Infant

Eligibility Criteria

Sex
ALL
Age
0 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Homebased SPEEDI — BEHAVIORAL
    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.
  • Telehealth SPEEDI — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Sep 15, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Homebased SPEEDI
    Parent-preterm infant dyads assigned to this arm will receive SPEEDI in the family home. The intervention will include 10 sessions over 15 weeks after baseline, beginning within 1 week after Visit 1.
  • Experimental: Telehealth SPEEDI
    Parent-preterm infant dyads assigned to this arm will receive SPEEDI via telehealth. The intervention will include 10 sessions over 15 weeks after baseline, beginning within 1 week after Visit 1.
  • No Intervention: Control
    Parent-preterm infant dyads assigned to this arm will complete study assessments at baseline, 15 weeks after baseline, and 30 weeks after baseline, but will not receive the SPEEDI intervention as part of the study.

Primary Outcome Measure

Feasibility of Initiating SPEEDI After NICU Discharge [ Time Frame: Baseline through 30 weeks after baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Masonic Institute for the Developing BrainMinneapolisMinnesota55414-
University of Minnesota Masonic Children's HospitalMinneapolisMinnesota55454-

Find similar trials in Minneapolis, MN

By research site
Masonic Institute for the Developing Brain· Minneapolis, MNUniversity of Minnesota Masonic Children's Hospital· Minneapolis, MN

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