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NCT Number: NCT07420686

Social Media and Risk-reduction Training for Preterm Infant Care Practices

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.

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Key information

Conditions

Safe Sleep Education Death Death, Sudden Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms SUID Sudden Infant Death Sudden Infant Death Syndrome (SIDS)

Age range

13 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01545, United States

Location contact

Mayra Rojas

CONTACT

[email protected]

5083346180

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Safe Sleep NICU Quality Improvement Campaign

Behavioral

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.

Shared Reading NICU Quality Improvement Campaign

Behavioral

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.

Safe Sleep TodaysNICUBaby videos and messages

Behavioral

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.

Shared Reading TodaysNICUBaby videos and messages

Behavioral

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.

Primary outcomes

  1. Impact of the NICU safe sleep intervention on safe infant sleep position

    Time frame: 60 days post-discharge

    Percent with exclusive supine sleep in the previous 2 weeks

  2. Impact of the NICU safe sleep intervention on safe infant sleep location

    Time frame: 60 days post-discharge

    Percent with exclusive room sharing without bedsharing in the previous 2 weeks

  3. Impact of the NICU safe sleep intervention safe sleep space

    Time frame: 60 days post-discharge

    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.)

  4. Impact of the NICU safe sleep intervention on safe infant sleep environment

    Time frame: 60 days post-discharge

    Percent with absence of loose objects in the sleep area in the previous 2 weeks

  5. Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep position

    Time frame: 60 days post-discharge

    Percent with exclusive supine sleep in the previous 2 weeks

  6. Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep location

    Time frame: 60 days post-discharge

    Percent with exclusive room sharing without bedsharing in the previous 2 weeks

  7. Impact of the mHealth post-discharge safe sleep intervention safe sleep space

    Time frame: 60 days post-discharge

    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.)

  8. Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep environment

    Time frame: 60 days post-discharge

    Percent with absence of loose objects in the sleep area in the previous 2 weeks

  9. Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep position

    Time frame: 60 days post-discharge

    Percent with exclusive supine sleep in the previous 2 weeks

  10. Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep location

    Time frame: 60 days post-discharge

    Percent with exclusive room sharing without bedsharing in the previous 2 weeks

  11. Impact of the NICU and mHealth post-discharge safe sleep intervention safe sleep space

    Time frame: 60 days post-discharge

    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.)

  12. Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep environment

    Time frame: 60 days post-discharge

    Percent with absence of loose objects in the sleep area in the previous 2 weeks

Secondary outcomes

  1. Safe infant sleep position by maternal race/ethnicity

    Time frame: 60 days post-discharge

    Percent with exclusive supine sleep in the previous 2 weeks, by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

  2. Safe infant sleep location by maternal race/ethnicit

    Time frame: 60 days post-discharge

    Percent with exclusive room sharing without bedsharing in the previous 2 weeks by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

  3. Safe sleep space by maternal race/ethnicity

    Time frame: 60 days post-discharge

    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)

  4. Safe infant sleep environment by maternal race/ethnicity

    Time frame: 60 days post-discharge

    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)

  5. Safe infant sleep position by infant gestational age

    Time frame: 60 days post-discharge

    Percent with exclusive supine sleep in the previous 2 weeks, by infant gestational age (<29 weeks vs 29-36 weeks)

  6. Safe infant sleep location by infant gestational age

    Time frame: 60 days post-discharge

    Percent with exclusive room sharing without bedsharing in the previous 2 weeks infant gestational age (<29 weeks vs 29-36 weeks)

  7. Safe sleep space by infant gestational age

    Time frame: 60 days post-discharge

    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)

  8. Safe infant sleep environment by infant gestational age

    Time frame: 60 days post-discharge

    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)

  9. Impact of the NICU safe sleep intervention on intention for safe infant sleep position

    Time frame: Baseline and 60 days post-discharge

    Percent with intention for exclusive supine sleep after NICU discharge

  10. Impact of the NICU safe sleep intervention on intention for safe infant sleep location

    Time frame: Baseline and 60 days post-discharge

    Percent with intention for exclusive room sharing without bedsharing after NICU discharge

  11. Impact of the NICU safe sleep intervention on intention for safe infant safe sleep space

    Time frame: Baseline and 60 days post-discharge

    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.)

  12. Impact of the NICU safe sleep intervention on intention for safe infant sleep environment

    Time frame: Baseline and 60 days post-discharge

    Percent with intention for no loose objects in the sleep area after NICU discharge

  13. Impact of the mHealth post-discharge sleep intervention on intention for safe infant sleep position

    Time frame: 60 days post-discharge

    Percent with intention for exclusive supine sleep after NICU discharge

  14. Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep location

    Time frame: 60 days post-discharge

    Percent with intention for exclusive room sharing without bedsharing after NICU discharge

  15. Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space

    Time frame: 60 days post-discharge

    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.)

  16. Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment

    Time frame: 60 days post-discharge

    Percent with intention for no loose objects in the sleep area after NICU discharge

  17. Impact of the NICU and mHealth post-discharge sleep intervention on intention for safe infant sleep position

    Time frame: 60 days post-discharge

    Percent with intention for exclusive supine sleep after NICU discharge

  18. Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep location

    Time frame: 60 days post-discharge

    Percent with intention for exclusive room sharing without bedsharing after NICU discharge

  19. Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space

    Time frame: 60 days post-discharge

    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.)

  20. Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment

    Time frame: 60 days post-discharge

    Percent with intention for no loose objects in the sleep area after NICU discharge

  21. Impact of the NICU safe sleep intervention on time to unsafe sleep position

    Time frame: 0 to 60 days post-discharge

    Time to place infant in an unsafe sleep position (any side or prone)

  22. Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep position

    Time frame: 0 to 60 days post-discharge

    Time to place infant in an unsafe sleep position (any side or prone)

  23. Impact of the NICU and mHealth post-discharge safe sleep intervention on time to unsafe sleep position

    Time frame: 0 to 60 days post-discharge

    Time to place infant in an unsafe sleep position (any side or prone)

  24. Impact of the NICU safe sleep intervention on time to unsafe sleep location

    Time frame: 0 to 60 days post-discharge

    Time to place infant in an unsafe sleep location (any bedsharing)

  25. Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep location

    Time frame: 0 to 60 days post-discharge

    Time to place infant in an unsafe sleep location (any bedsharing)

  26. Impact of the NICU and mHealth post-discharge safe sleep intervention on unsafe sleep location

    Time frame: 0 to 60 days post-discharge

    Time to place infant in an unsafe sleep location (any bedsharing)

  27. Impact of the NICU shared reading intervention on reading

    Time frame: 60 days post-discharge

    Score on the READ scale of the STIM-Q

  28. Impact of the post-discharge mHealth shared reding intervention on reading

    Time frame: 60 days post-discharge

    Score on the READ scale of the STIM-Q

  29. Impact on the NICU and post-discharge mHealth shared reading interventions on reading

    Time frame: 60 days post-discharge

    Score on the READ scale of the STIM-Q

  30. Impact of the NICU shared reading intervention on early relational health

    Time frame: 60 days post-discharge

    Score on the post-partum bonding questionnaire

  31. Impact of the post-discharge mHealth shared reding intervention on early relational health

    Time frame: 60 days post-discharge

    Score on the post-partum bonding questionnaire

  32. Impact on the NICU and post-discharge mHealth shared reading interventions on early relational health

    Time frame: 60 days post-discharge

    Score on the post-partum bonding questionnaire

  33. Reading by maternal race/ethnicity

    Time frame: 60 days post-discharge

    Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

  34. Early relational health by race/ethnicity

    Time frame: 60 days post-discharge

    Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)

  35. Reading by infant gestational age

    Time frame: 60 days post-discharge

    Score on the post-partum bonding questionnaire by infant gestational age ( <29 weeks vs 29-36 weeks)

  36. Early relational health by infant gestational age

    Time frame: 60 days post-discharge

    Score on the post-partum bonding questionnaire by infant gestational age (<29 weeks vs 29-36 weeks)

  37. Feasibility of NICU interventions

    Time frame: In year 4-5 of study period, after completion of enrollment on subjects

    Mean score reported by NICU staff on the Feasibility of Intervention Measure (FIM), a 4-item measure of perceived intervention feasibility

  38. Acceptability of NICU interventions

    Time frame: In year 4-5 of study period, after completion of enrollment on subjects

    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

  39. Fidelity to NICU safe sleep intervention

    Time frame: Baseline

    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

  40. Fidelity to NICU shared reading intervention

    Time frame: Baseline

    Percentage of mothers reporting participation in shared reading and receipt of shared reading education while in the NICU

  41. Fidelity to mHealth interventions

    Time frame: Days 1-60 post-discharge

    Percentage of videos opened by mothers as a proxy for videos watched

Study contacts

Contact information is provided by the study sponsor or research team.

Margaret Parker, MD, MPH

CONTACT

[email protected]

5083343180

Mayra Rojas, BS

CONTACT

[email protected]

5083343180

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

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

Registry information

Acronym: SMART Preemie

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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