Health TrialsbyHealthPanel

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

ConditionsPreterm BirthVery Preterm InfantInfant DevelopmentNeonatal Intensive Care Unit
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorUniversity of Minnesota

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Homebased SPEEDIExperimental treatment 1 intervention
Group B: Telehealth SPEEDIExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline through 30 weeks after baseline

Secondary outcomes

1

Family Experience With SPEEDI

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.

Time frame
Between 15 weeks and 30 weeks after baseline
2

Provider-Reported Strengths and Barriers to SPEEDI Implementation

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.

Time frame
During study participation, through study completion

Other outcomes

1

Change in Parent-Infant Emotional Availability

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.

Time frame
Baseline, 15 weeks after baseline, and 30 weeks after baseline
2

Change in Infant Motor Performance

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

Time frame
Baseline and 15 weeks after baseline
3

Change in Infant Developmental Function

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

Time frame
15 weeks after baseline and 30 weeks after baseline
4

Infant Movement and Posture at Follow-up

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.

Time frame
30 weeks after baseline

Sponsors and contacts

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University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: