Dyadic Support for Preterm Infants
(MN-SPEEDI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Corri Stuyvenberg, PT, DPT, PhD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for families with very preterm infants (born much earlier than due) who have just been discharged from the NICU. Both the infant and a parent or caregiver must be able to participate in early development activities at home.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Homebased SPEEDI
- Telehealth SPEEDI
Trial Overview
The study compares two ways of delivering an early developmental support program called SPEEDI: one group gets it through home visits, another via telehealth sessions, and a third group receives usual care. The goal is to see which method works best for families after NICU discharge.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
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