Social Media and Risk-reduction Training for Preterm Infant Care Practices (SMART Preemie)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: SUID; Sudden Infant Death Syndrome (SIDS); Safe Sleep Education
• Intervention / Treatment: Behavioral: Safe Sleep NICU Quality Improvement Campaign; Behavioral: Shared Reading TodaysNICUBaby videos and messages; Behavioral: Shared Reading NICU Quality Improvement Campaign; Behavioral: Safe Sleep TodaysNICUBaby videos and messages

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret Parker, MD, MPH; Phone Number: 5083343180; Email: Margaret.Parker@umassmemorial.org
• Study Contact Backup: Name: Mayra Rojas, BS; Phone Number: 5083343180; Email: mayra.rojascorrea@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01545
      • University of Massachusetts Chan Medical School
      • Contact: Mayra Rojas; Phone Number: 5083346180; Email: mayra.rojascorrea@umassmed.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

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)
• Meets the definition of a minor according to applicable state law.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages	Behavioral: Safe Sleep NICU Quality Improvement Campaign; 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.; Behavioral: Shared Reading TodaysNICUBaby videos and messages; The Shared Reading TodaysNICUBaby mHealth program is comprised of: text message-delivered, short educational videos in the first 8 weeks after NICU discharge and; text queries regarding shared reading, which collect data on these practices in near real-time and provide reinforcement of adherence.
Experimental: Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages	Behavioral: Shared Reading NICU Quality Improvement Campaign; We will train NICU staff working in hospitals randomized to the shared reading intervention to: Model shared reading practices with book distribution, and; 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.; Behavioral: Safe Sleep TodaysNICUBaby videos and messages; The TodaysNICUBaby mHealth program is comprised of: text message-delivered, short educational videos in the first 8 weeks after NICU discharge and; text queries regarding safe sleep or shared reading practices, which collect data on these practices in near real-time and provide reinforcement of adherence.
Experimental: Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages	Behavioral: Safe Sleep NICU Quality Improvement Campaign; 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.; Behavioral: Safe Sleep TodaysNICUBaby videos and messages; The TodaysNICUBaby mHealth program is comprised of: text message-delivered, short educational videos in the first 8 weeks after NICU discharge and; text queries regarding safe sleep or shared reading practices, which collect data on these practices in near real-time and provide reinforcement of adherence.
Other: Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag	Behavioral: Shared Reading TodaysNICUBaby videos and messages; The Shared Reading TodaysNICUBaby mHealth program is comprised of: text message-delivered, short educational videos in the first 8 weeks after NICU discharge and; text queries regarding shared reading, which collect data on these practices in near real-time and provide reinforcement of adherence.; Behavioral: Shared Reading NICU Quality Improvement Campaign; We will train NICU staff working in hospitals randomized to the shared reading intervention to: Model shared reading practices with book distribution, and; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safe infant sleep position by maternal race/ethnicity	Percent with exclusive supine sleep in the previous 2 weeks, by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)	60 days post-discharge
Safe infant sleep location by maternal race/ethnicit	Percent with exclusive room sharing without bedsharing in the previous 2 weeks by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)	60 days post-discharge
Safe sleep space by maternal race/ethnicity	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.) by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)	60 days post-discharge
Safe infant sleep environment by maternal race/ethnicity	Percent with absence of loose objects in the sleep space in the previous 2 weeks by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)	60 days post-discharge
Safe infant sleep position by infant gestational age	Percent with exclusive supine sleep in the previous 2 weeks, by infant gestational age (<29 weeks vs 29-36 weeks)	60 days post-discharge
Safe infant sleep location by infant gestational age	Percent with exclusive room sharing without bedsharing in the previous 2 weeks infant gestational age (<29 weeks vs 29-36 weeks)	60 days post-discharge
Safe sleep space by infant gestational age	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.) infant gestational age (<29 weeks vs 29-36 weeks)	60 days post-discharge
Safe infant sleep environment by infant gestational age	Percent with absence of loose objects in the sleep space in the previous 2 weeks by infant gestational age (<29 weeks vs 29-36 weeks)	60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep position	Percent with intention for exclusive supine sleep after NICU discharge	Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep location	Percent with intention for exclusive room sharing without bedsharing after NICU discharge	Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant safe sleep space	Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.)	Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep environment	Percent with intention for no loose objects in the sleep area after NICU discharge	Baseline and 60 days post-discharge
Impact of the mHealth post-discharge sleep intervention on intention for safe infant sleep position	Percent with intention for exclusive supine sleep after NICU discharge	60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep location	Percent with intention for exclusive room sharing without bedsharing after NICU discharge	60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space	Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (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 intention for safe infant sleep environment	Percent with intention for no loose objects in the sleep area after NICU discharge	60 days post-discharge
Impact of the NICU and mHealth post-discharge sleep intervention on intention for safe infant sleep position	Percent with intention for exclusive supine sleep after NICU discharge	60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep location	Percent with intention for exclusive room sharing without bedsharing after NICU discharge	60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space	Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (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 intention for safe infant sleep environment	Percent with intention for no loose objects in the sleep area after NICU discharge	60 days post-discharge
Impact of the NICU safe sleep intervention on time to unsafe sleep position	Time to place infant in an unsafe sleep position (any side or prone)	0 to 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep position	Time to place infant in an unsafe sleep position (any side or prone)	0 to 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on time to unsafe sleep position	Time to place infant in an unsafe sleep position (any side or prone)	0 to 60 days post-discharge
Impact of the NICU safe sleep intervention on time to unsafe sleep location	Time to place infant in an unsafe sleep location (any bedsharing)	0 to 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep location	Time to place infant in an unsafe sleep location (any bedsharing)	0 to 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on unsafe sleep location	Time to place infant in an unsafe sleep location (any bedsharing)	0 to 60 days post-discharge
Impact of the NICU shared reading intervention on reading	Score on the READ scale of the STIM-Q	60 days post-discharge
Impact of the post-discharge mHealth shared reding intervention on reading	Score on the READ scale of the STIM-Q	60 days post-discharge
Impact on the NICU and post-discharge mHealth shared reading interventions on reading	Score on the READ scale of the STIM-Q	60 days post-discharge
Impact of the NICU shared reading intervention on early relational health	Score on the post-partum bonding questionnaire	60 days post-discharge
Impact of the post-discharge mHealth shared reding intervention on early relational health	Score on the post-partum bonding questionnaire	60 days post-discharge
Impact on the NICU and post-discharge mHealth shared reading interventions on early relational health	Score on the post-partum bonding questionnaire	60 days post-discharge
Reading by maternal race/ethnicity	Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)	60 days post-discharge
Early relational health by race/ethnicity	Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)	60 days post-discharge
Reading by infant gestational age	Score on the post-partum bonding questionnaire by infant gestational age ( <29 weeks vs 29-36 weeks)	60 days post-discharge
Early relational health by infant gestational age	Score on the post-partum bonding questionnaire by infant gestational age (<29 weeks vs 29-36 weeks)	60 days post-discharge
Feasibility of NICU interventions	Mean score reported by NICU staff on the Feasibility of Intervention Measure (FIM), a 4-item measure of perceived intervention feasibility	In year 4-5 of study period, after completion of enrollment on subjects
Acceptability of NICU interventions	Mean score reported by NICU staff on the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability. Scores are calculated as the mean	In year 4-5 of study period, after completion of enrollment on subjects
Fidelity to NICU safe sleep intervention	Percentage of mothers reporting observed modeling of safe sleep practices (supine sleep position and absence of objects in the sleep environment) and receipt of safe sleep education while in the NICU	Baseline
Fidelity to NICU shared reading intervention	Percentage of mothers reporting participation in shared reading and receipt of shared reading education while in the NICU	Baseline
Fidelity to mHealth interventions	Percentage of videos opened by mothers as a proxy for videos watched	Days 1-60 post-discharge

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Boston University; University of Colorado, Denver; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Washington University School of Medicine; New York University; Boston Medical Center; University of Virginia

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death; Death, Sudden; Pathological Conditions, Signs and Symptoms; Infant Death; Sudden Infant Death
• Other Study ID Numbers: STUDY00002732; 2R01HD095060-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No