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
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 aims to evaluate the effectiveness of different educational programs in helping mothers of preterm infants follow safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS). It will compare four approaches using videos, messages on safe sleep, and shared reading activities. The researchers aim to identify the best methods to promote safe sleep habits that can be shared nationwide. Mothers with preterm infants who stayed in a Neonatal Intensive Care Unit (NICU) for at least a week and are returning home with them may be eligible to participate. As an unphased trial, this study offers a unique opportunity to contribute to research that could benefit families across the country.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research shows that Safe Sleep programs are generally easy for participants to manage. These programs instruct parents and caregivers on reducing the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths. Studies have found that these programs help hospital nurses and parents adopt better practices, resulting in fewer sleep-related incidents.

For Shared Reading programs, research suggests that reading books together in Neonatal Intensive Care Units (NICUs) benefits both infants and caregivers. This program supports language and literacy development without any negative effects.

Both programs focus on education and behavior, are non-invasive, and maintain a strong safety record. They aim to improve care practices, making them safe and practical choices for participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving education and awareness to prevent Sudden Infant Death Syndrome (SIDS) through innovative approaches in the NICU. The trial uses a unique combination of Safe Sleep and Shared Reading Quality Improvement Campaigns, along with TodaysNICUBaby videos and messages, to educate parents and caregivers. These methods are distinct because they integrate educational content into routine NICU care, making it accessible and engaging for families. By enhancing understanding and promoting safe sleep practices right from the NICU, this trial aims to reduce the risk of SIDS and improve infant health outcomes.

What evidence suggests that this trial's interventions could be effective for promoting safe sleep practices?

Research has shown that educating parents and caregivers about safe sleep significantly improves the implementation of these practices. For instance, studies have found that participants felt twice as confident about safe sleep practices after attending these programs. These educational efforts also lead to better understanding and habits in caring for babies, which can help lower the risk of Sudden Infant Death Syndrome (SIDS). In this trial, participants will engage in various educational programs, such as the Safe Sleep NICU Quality Improvement Campaign and TodaysNICUBaby videos and messages, to assess their effectiveness. The Safe to Sleep campaign has successfully taught many people how to reduce the chances of sleep-related infant deaths. This evidence suggests that programs promoting safe sleep habits are both effective and helpful.13678

Are You a Good Fit for This Trial?

This trial is for English- or Spanish-speaking mothers of preterm infants (born before 37 weeks) who are being discharged from one of 16 participating NICUs in the US. Mothers must plan to care for their baby at home, have a phone that can get texts and videos, and be able to give consent. Certain health or custody issues may exclude participation.

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

Trial Overview

The study tests different ways—like educational videos, text messages, and quality improvement campaigns—to teach safe sleep practices for preterm babies. Hospitals are randomly assigned to use these strategies alone or in combination, with some groups focusing on shared reading as a control.

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+

Citations

Safe Sleep Education for Sudden Infant Death Syndrome ...

SMART Preemie is a cluster randomized trial that will investigate the effectiveness of NICU-based and post-discharge interventions to ...

2.

safetosleep.nichd.nih.gov

safetosleep.nichd.nih.gov/

Safe to Sleep: Homepage

The Safe to Sleep® campaign educates parents, caregivers, providers, & others about reducing the risk of SIDS, SUID & other sleep-related infant death.

Published Results Show Improved NICU Safe Sleep ...

Published Results Show Improved NICU Safe Sleep Outcomes · 100% increased confidence in safe sleep practices · 93% felt culturally respected · 96% ...

Resources to support safe infant sleep

Here you'll find strategies and interactive resources to promote safe infant sleep recommendations, along with lessons learned to empower health professionals.

An Evidence‐Based Safe Sleep Program Is Associated ... - PMC

A safe sleep program improved hospital‐based nurses' knowledge and practice and birth parent's knowledge and behaviors, and it was associated with a decrease ...

Safe Sleep for Your Baby

This 10-minute video is part of the Safe to Sleep campaign ... sudden infant death syndrome (SIDS) and other sleep-related causes of infant death.

Resources

Welcome to NICHQ's official guide to ensuring safe infant sleep! Here you'll find strategies and interactive resources to promote safe infant sleep ...

Safe Sleep Campaign Toolkit

The leading cause of death for infants 1 month to 1 year is Sudden Unexpected Infant Death (SUIDs). This includes sleep related deaths and SIDS.