Social Media and Risk-reduction Training for Preterm Infant Care Practices
SMART Preemie
2 other identifiers
interventional
1,600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
Study Completion
Last participant's last visit for all outcomes
December 31, 2028
May 13, 2026
February 1, 2026
1.5 years
February 12, 2026
May 9, 2026
Conditions
Outcome Measures
Primary Outcomes (12)
Impact of the NICU safe sleep intervention on safe infant sleep position
Percent with exclusive supine sleep in the previous 2 weeks
60 days post-discharge
Impact of the NICU safe sleep intervention on safe infant sleep location
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
60 days post-discharge
Impact of the NICU safe sleep intervention safe sleep space
Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)
60 days post-discharge
Impact of the NICU safe sleep intervention on safe infant sleep environment
Percent with absence of loose objects in the sleep area in the previous 2 weeks
60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep position
Percent with exclusive supine sleep in the previous 2 weeks
60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep location
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention safe sleep space
Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)
60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep environment
Percent with absence of loose objects in the sleep area in the previous 2 weeks
60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep position
Percent with exclusive supine sleep in the previous 2 weeks
60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep location
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention safe sleep space
Percent with exclusive sleep in a crib/bassinet in the previous 2 weeks (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)
60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep environment
Percent with absence of loose objects in the sleep area in the previous 2 weeks
60 days post-discharge
Secondary Outcomes (41)
Safe infant sleep position by maternal race/ethnicity
60 days post-discharge
Safe infant sleep location by maternal race/ethnicit
60 days post-discharge
Safe sleep space by maternal race/ethnicity
60 days post-discharge
Safe infant sleep environment by maternal race/ethnicity
60 days post-discharge
Safe infant sleep position by infant gestational age
60 days post-discharge
- +36 more secondary outcomes
Study Arms (4)
Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages
EXPERIMENTALShared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
EXPERIMENTALSafe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
EXPERIMENTALShared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag
OTHERInterventions
We will train NICU staff working in hospitals randomized to the safe sleep intervention to: (1) Model safe sleep practices when infants achieve medical stability according to AAP guidelines ; and (2) Provide education to parents about safe sleep throughout the NICU hospitalization, as it relates to their infants reaching medical stability and readiness to be placed in supine positions in a sleep area without any unsafe objects in the NICU and in the home environment.
We will train NICU staff working in hospitals randomized to the shared reading intervention to: 1. Model shared reading practices with book distribution, and 2. Provide education to parents about shared reading. Hospital staff may use any materials from our toolkits as needed and we ask for staff to provide education to parents, and model shared reading, when distributing a new book to the family within the first week of admission, and then every 2 weeks while their child is in the NICU.
The TodaysNICUBaby mHealth program is comprised of: 1. text message-delivered, short educational videos in the first 8 weeks after NICU discharge and 2. text queries regarding safe sleep or shared reading practices, which collect data on these practices in near real-time and provide reinforcement of adherence.
The Shared Reading TodaysNICUBaby mHealth program is comprised of: 1. text message-delivered, short educational videos in the first 8 weeks after NICU discharge and 2. text queries regarding shared reading, which collect data on these practices in near real-time and provide reinforcement of adherence.
Eligibility Criteria
You may qualify if:
- English- or Spanish- speaking mothers of preterm infants (gestational age \<37 weeks' weeks)
- Infant must have been admitted to one of the 16 participating NICUs for at least 7 days
- Infant must be discharged home from one of the 16 participating NICUs within 56 weeks post-menstrual age (\>95% of preterm infants)
- 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
You may not qualify if:
- 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)
- Meets the definition of a minor according to applicable state law.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Massachusetts, Worcesterlead
- Washington University School of Medicinecollaborator
- Boston Medical Centercollaborator
- Boston Universitycollaborator
- University of Virginiacollaborator
- New York Universitycollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- University of Colorado, Denvercollaborator
Study Sites (1)
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01545, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 19, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
May 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share