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NCT Number: NCT07820462

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Infant Development Neonatal Intensive Care Unit Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Very Preterm Infant

Age range

0 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masonic Institute for the Developing Brain, Minneapolis, Minnesota, United States

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About this study

Very preterm infants and their families may experience challenges during the transition from the neonatal intensive care unit to home. Early intervention during this transition may support parent-infant relationships, infant development, and family confidence.

This feasibility study will evaluate whether the Supporting Play Exploration and Early Development Intervention can be initiated 1 to 5 days after NICU discharge and delivered in either homebased or telehealth contexts. The study will enroll 40 parent-preterm infant dyads from the University of Minnesota Masonic Children's Hospital NICU. Infants will have been born at less than 32 weeks gestation and discharged from the NICU between 35 and 44 weeks postmenstrual age.

After baseline assessment, parent-infant dyads will be assigned to homebased SPEEDI, telehealth SPEEDI, or control. Families in the homebased and telehealth groups will receive 10 intervention sessions across 15 weeks. SPEEDI is grounded in positive parent-infant relationship building and supports parents in interpreting infant behavioral cues and stress signs, increasing parenting confidence, and engaging infants in developmentally appropriate therapeutic play.

Assessments will occur at Visit 1, 1 to 5 days after NICU discharge; Visit 2, 15 weeks after baseline; and Visit 3, 30 weeks after baseline. Study assessments include parent questionnaires, parent-infant interaction videos scored with the Emotional Availability Scale, infant motor and developmental assessments, and infant activity measurement using the Motor Assessment of Infants with Jumpsuit at Visit 3.

The primary focus of the study is feasibility rather than efficacy. Feasibility measures include recruitment, dropout rate, intervention and assessment attendance, parent activity log completion, SPEEDI adherence, and differentiation between telehealth and homebased delivery. Qualitative interviews with families and Part C Early Intervention providers will be used to identify experiences, strengths, and barriers relevant to future implementation studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Supporting Play Exploration and Early Development Intervention

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.

Other names: Supporting Play Exploration and Early Development Intervention via Telehealth

Primary outcomes

  1. Feasibility of Initiating SPEEDI After NICU Discharge

    Time frame: Baseline through 30 weeks after baseline

    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.

Secondary outcomes

  1. Family Experience With SPEEDI

    Time frame: Between 15 weeks and 30 weeks after baseline

    Qualitative interviews will be conducted with families receiving homebased or telehealth SPEEDI to assess family experiences, including perceived strengths, barriers, benefits, harms, confidence interacting with the infant, and confidence reading infant cues.

  2. Provider-Reported Strengths and Barriers to SPEEDI Implementation

    Time frame: During study participation, through study completion

    Qualitative interviews or focus groups with Part C Early Intervention providers will assess perceived strengths and barriers to implementing SPEEDI in urban and rural settings.

Other outcomes

  1. Change in Parent-Infant Emotional Availability

    Time frame: Baseline, 15 weeks after baseline, and 30 weeks after baseline

    Low-efficacy outcome: Change in parent-infant emotional availability will be assessed using the Emotional Availability Scale from video-recorded parent-infant interactions. This outcome will be evaluated as an exploratory/low-efficacy outcome because the primary focus of this feasibility study is feasibility, not efficacy.

  2. Change in Infant Motor Performance

    Time frame: Baseline and 15 weeks after baseline

    Low-efficacy outcome: Infant motor performance will be assessed using the Test of Infant Motor Performance.

  3. Change in Infant Developmental Function

    Time frame: 15 weeks after baseline and 30 weeks after baseline

    Low-efficacy outcome: Infant developmental function will be assessed using the Bayley Scales of Infant and Toddler Development-4.

  4. Infant Movement and Posture at Follow-up

    Time frame: 30 weeks after baseline

    Low-efficacy outcome: Infant movement and posture will be assessed using the Motor Assessment of Infants with Jumpsuit during a 30-minute data collection session at the follow-up visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Corri Stuyvenberg, PT, DPT, PhD

CONTACT

[email protected]

952-818-1309

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: MN-SPEEDI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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