| Registry | NCT07420686, acronym SMART Preemie |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, factorial, masking: none, prevention |
| Enrollment | 1600 (Estimated) |
| Sponsor | University of Massachusetts, Worcester (Other); collaborators: Washington University School of Medicine, Boston Medical Center, Boston University, University of Virginia, New York University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver |
| Conditions | Safe Sleep Education, SUID, Sudden Infant Death Syndrome (SIDS) |
| Interventions | Safe Sleep NICU Quality Improvement Campaign, Shared Reading NICU Quality Improvement Campaign, Safe Sleep TodaysNICUBaby videos and messages, Shared Reading TodaysNICUBaby videos and messages (Behavioral) |
| Dates | start 2027-01-01 (estimated), primary completion 2028-06-30 (estimated), completion 2028-12-31 (estimated), first posted 2026-02-19, last updated 2026-05-13 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Safe Sleep Education All trials for SUID All trials of Safe Sleep NICU Quality Improvement Campaign All trials of Shared Reading NICU Quality Improvement Campaign
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages | Experimental | Behavioral: Safe Sleep NICU Quality Improvement Campaign; Behavioral: Shared Reading TodaysNICUBaby videos and messages | |
| Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages | Experimental | Behavioral: Shared Reading NICU Quality Improvement Campaign; Behavioral: Safe Sleep TodaysNICUBaby videos and messages | |
| Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages | Experimental | Behavioral: Safe Sleep NICU Quality Improvement Campaign; Behavioral: Safe Sleep TodaysNICUBaby videos and messages | |
| Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag | Other | Behavioral: Shared Reading NICU Quality Improvement Campaign; Behavioral: Shared Reading TodaysNICUBaby videos and messages |
Sex: Female, ages: 13 Years to any, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Massachusetts Chan Medical School | Worcester, Massachusetts | United States |
NIH grants: R01HD095060