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

NCT07820462 | Not Yet Recruiting

• 1 other identifier: CTSI-34485
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

MN-SPEEDI; Supporting Play Exploration and Early Development Intervention; Early Intervention; NICU discharge; Parent-infant dyad; Telehealth intervention

Outcome Measures

Primary Outcomes (1)

• Feasibility of Initiating SPEEDI After NICU Discharge

  Feasibility will be assessed using recruitment of 40 dyads within 6 to 9 months, dropout rate less than 10%, intervention session attendance of 80%, assessment session attendance of 90%, parent activity log completion of 80%, SPEEDI interventionist and parent adherence to key protocol components of 90%, and less than 10% differentiation between telehealth and homebased SPEEDI components.

  Baseline through 30 weeks after baseline

Secondary Outcomes (2)

• Family Experience With SPEEDI

  Between 15 weeks and 30 weeks after baseline

• Provider-Reported Strengths and Barriers to SPEEDI Implementation

  During study participation, through study completion

Other Outcomes (4)

• Change in Parent-Infant Emotional Availability

  Baseline, 15 weeks after baseline, and 30 weeks after baseline

• Change in Infant Motor Performance

  Baseline and 15 weeks after baseline

• Change in Infant Developmental Function

  15 weeks after baseline and 30 weeks after baseline

Study Arms (3)

Homebased SPEEDI

EXPERIMENTAL

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.

Behavioral: Homebased SPEEDI

Telehealth SPEEDI

EXPERIMENTAL

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.

Behavioral: Telehealth SPEEDI

Control

NO INTERVENTION

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.

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.

Also known as: Supporting Play Exploration and Early Development Intervention

Homebased SPEEDI

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.

Also known as: Supporting Play Exploration and Early Development Intervention via Telehealth

Telehealth SPEEDI

Eligibility Criteria

• Age: 0 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent obtained from participant and ability for participant to comply with study requirements
• Stated willingness to comply with all study procedures, including consenting parent attendance at all study assessment and intervention visits
• Stated willingness to comply with assignment to the homebased, telehealth, or control group
• Infant gestational age of less than 32 weeks at birth
• Infant hospitalized for more than 28 days following preterm birth
• Infant discharged from the NICU between 35 and 44 weeks postmenstrual age
• Consenting parent plans to live in Minnesota for a minimum of 6 months from recruitment
• Consenting parent must be able to understand and speak English
• Consenting parent age 18 years or older

You may not qualify if:

• Infant has a genetic syndrome or metabolic disorder known to be progressive or to have developmental consequences
• Infant has a condition that is not compatible with life
• Prisoners with infants in the NICU
• Pregnant women/persons
• Fetuses
• Neonates
• Non-English speakers
• Employees of the researcher
• Students of the researcher

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

Masonic Institute for the Developing Brain

Minneapolis, Minnesota, 55414, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Corri Stuyvenberg, PT, DPT, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corri Stuyvenberg, PT, DPT, PhD

CONTACT

952-818-1309; stuyv006@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parent-preterm infant dyads will be assigned to one of three groups: homebased SPEEDI, telehealth SPEEDI, or control. Following baseline assessment after NICU discharge, dyads will be randomized to homebased intervention, telehealth intervention, or control, except families living outside an "entirely urban" designated county will be assigned to telehealth. Assessments will occur at baseline, 15 weeks after baseline, and 30 weeks after baseline.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

US (2)