Search > Safe Sleep Education
My employer runs this trial

Safe Sleep Education for Sudden Infant Death Syndrome

(SMART Preemie Trial)

MP
MR
Overseen ByMayra Rojas, BS
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
Disqualifiers: Mental health issues, Infant contraindications, others
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?

SMART Preemie is a cluster randomized trial that will investigate the effectiveness of NICU-based and post-discharge interventions to improve adherence to safe sleep practices among mothers of preterm infants. This study includes two complementary, culturally competent, intervention strategies and will test the effectiveness of each strategy, as well as both strategies in combination. The attention matched-control intervention will focus on shared reading.

The SMART Preemie study will have four arms in which 16 hospitals are randomly assigned to one of the following study groups: 1) Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages; 2) Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 3) Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages; 4) Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages. A total of 1600 mothers will be recruited (100/hospital), with 400 in each study group.

The primary aim is to assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the shared reading control interventions. The secondary aim is to assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches. The tertiary aim is to assess key implementation outcomes which will be used for future scale-up. With the successful completion of the SMART Preemie study, effectiveness, mechanism, and implementation data will have been provided for two interventions to improve adherence to safe sleep practices that are practical to disseminate nationally in multiple diverse settings.

Are You a Good Fit for This Trial?

Inclusion Criteria

Infant must be discharged to the care of the mother (not a foster family) who intends to care for the child in the US for the first 6 months post-discharge
Must have a phone that can receive text messages and view videos
Infant must have been admitted to one of the 16 participating NICUs for at least 7 days
See 2 more

Exclusion Criteria

Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process
Infant has contraindications to safe sleep positioning (e.g. extremely rare conditions of the airway or lower spine)
I am considered a minor under my state's laws.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

NICU Intervention

Implementation of NICU-based interventions focusing on safe sleep practices and shared reading

Duration of NICU stay
Ongoing during NICU stay

Post-discharge Intervention

mHealth interventions to promote safe sleep practices post-discharge

60 days
Remote monitoring and follow-up

Follow-up

Participants are monitored for adherence to safe sleep practices and other outcomes

60 days post-discharge
Remote follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Safe Sleep NICU Quality Improvement Campaign
  • Safe Sleep TodaysNICUBaby videos and messages
  • Shared Reading NICU Quality Improvement Campaign
  • Shared Reading TodaysNICUBaby videos and messages

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messagExperimental Treatment2 Interventions
Group II: Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messagesExperimental Treatment2 Interventions
Group III: Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messagesExperimental Treatment2 Interventions
Group IV: Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messagesExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+

Boston Medical Center

Collaborator

Trials
410
Recruited
890,000+

University of Virginia

Collaborator

Trials
802
Recruited
1,342,000+

New York University

Collaborator

Trials
249
Recruited
229,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

Boston University

Collaborator

Trials
494
Recruited
9,998,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.