An interventional study of Homebased SPEEDI and Telehealth SPEEDI in Preterm Birth, Very Preterm Infant and Infant Development, sponsored by University of Minnesota. Not yet recruiting at 2 sites in United States. Open to participants aged 0 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of Minnesota · Not applicable, Interventional, and Supportive care
Among 11 studies in Premature Birth by University of Minnesota — 3 open to participants now, 4 under way, none of them phase 3. Premature Birth · University of Minnesota.
Among the 11 studies in Premature Birth by University of Minnesota, this one is the only one that started in 2026, is one of 4 with no phase, and was the 11th registered.
2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.
Browse Premature Birth studies →3 of the 11 studies in Premature Birth by University of Minnesota are open now, in 1 country. Recruiting first, the newest first:
University of Minnesota · Sites in United States
Ages 22 wk–31 wk
University of Minnesota · Sites in United States
Ages 28 wk–34 wk
By country, each count listing its studies:
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: 0 Years to 6 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 40 is below the median of 84 across 1,669 interventional studies indexed under Premature Birth.
Median enrollment 40 across the 5 interventional studies, 74 across the 6 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
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University of Minnesota is the lead sponsor of 1,216 studies on the registry; 196 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
2 of the studies in Premature Birth by University of Minnesota that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07049900University of MinnesotaBaby ABS (Abdominal Binder Study) | 2027-04-30 |
| NCT05537454University of MinnesotaMaternal Stress, Milk Composition, and Preterm Neurodevelopment | 2027-07-31 |
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Among the 11 studies in Premature Birth by University of Minnesota, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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
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
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
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
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
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
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
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
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
Start is estimated for Nov 2026; primary completion for Dec 2028, 24 months later.
Of 744 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 24 months is close to that.
Counting every sponsor, half of 762 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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