Dyadic Support for Preterm Infants

(MN-SPEEDI Trial)

Not yet recruiting at 1 trial location
CS
Overseen ByCorri Stuyvenberg, PT, DPT, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called SPEEDI, which supports parents of very preterm infants by enhancing their confidence and understanding of their baby's cues through play. The researchers aim to assess how effectively this program can be delivered at home (Homebased SPEEDI) or via telehealth (Telehealth SPEEDI) after babies leave the neonatal intensive care unit (NICU). The study will also examine the strengths and challenges of each method. Families with an infant born before 32 weeks, who stayed in the hospital for over 28 days, and plan to live in Minnesota for at least 6 months, might be suitable for this study. As an unphased trial, this study offers families the chance to contribute to innovative care strategies for preterm infants.

What prior data suggests that the SPEEDI intervention is safe for preterm infants and their families?

Research has shown that both Homebased SPEEDI and Telehealth SPEEDI are safe for preterm infants and their families.

Homebased SPEEDI involves no drugs or medical devices, and no negative effects from the program itself have been reported. It emphasizes play and interaction to support parents and infants, which is generally well-received.

For Telehealth SPEEDI, studies indicate that remote support can improve outcomes. Specifically, tele-nursing has reduced hospital visits for premature infants and increased parents' confidence and connection with their babies. Thus, Telehealth SPEEDI is not only safe but may also offer additional benefits by enabling families to maintain healthcare support from home.

Both methods aim to strengthen the bond and understanding between parents and infants, with no known risks or safety concerns reported.12345

Why are researchers excited about this trial?

Researchers are excited about the Dyadic Support for Preterm Infants trial because it explores innovative ways to support the development of preterm infants through the SPEEDI program. Unlike traditional in-person therapy sessions, the Homebased SPEEDI delivers personalized interventions directly in the family's home, enhancing convenience and comfort for both parents and infants. Meanwhile, the Telehealth SPEEDI offers remote access to similar support, allowing flexibility and accessibility for families who might face barriers to attending in-person sessions. These approaches aim to provide comprehensive support during a critical developmental period, with the hope of improving long-term outcomes for preterm infants.

What evidence suggests that this trial's interventions could be effective for preterm infants?

This trial will compare the effectiveness of two versions of the Supporting Play Exploration and Early Development Intervention (SPEEDI) for preterm infants: Homebased SPEEDI and Telehealth SPEEDI. Research has shown that SPEEDI could benefit very preterm infants. Although specific data on Homebased SPEEDI is limited, similar programs have positively impacted early childhood development. In contrast, more evidence supports the Telehealth SPEEDI arm. Studies have found that telehealth programs can reduce hospital readmissions for premature infants and enhance parents' confidence and bonding with their babies. Additionally, telehealth has improved movement and cognitive skills in similar early programs. These findings suggest that SPEEDI, particularly when delivered through telehealth, may effectively support the development of preterm infants and strengthen parent-infant relationships.678910

Who Is on the Research Team?

CS

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

Stated willingness to comply with all study procedures, including consenting parent attendance at all study assessment and intervention visits
Written informed consent obtained from participant and ability for participant to comply with study requirements
My baby was born before 32 weeks of pregnancy.
See 6 more

Exclusion Criteria

Prisoners with infants in the NICU
Fetuses
Students of the researcher
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Baseline assessments conducted including parent questionnaires and parent-infant interaction videos

1 week
1 visit (in-person)

Intervention

SPEEDI intervention delivered either homebased or via telehealth, consisting of 10 sessions over 15 weeks

15 weeks
10 sessions (homebased or telehealth)

Follow-up

Participants are monitored for feasibility and family experiences with SPEEDI, including qualitative interviews

15 weeks
2 visits (in-person)

Extended Follow-up

Final assessments including infant motor and developmental assessments and qualitative interviews with providers

15 weeks
1 visit (in-person)

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

Group I: Telehealth SPEEDIExperimental Treatment1 Intervention
Group II: Homebased SPEEDIExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

1.

outcomes.com

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Outcomes | Healthcare Solutions for Pharmacy, Pharma, and ...

The Outcomes platform is the ideal solution for gaining insight across the entire treatment journey. Gain access to all the data you need to improve medication ...

2.

secure.outcomesmtm.com

secure.outcomesmtm.com/

Outcomes Login

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3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31422062/

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