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

University of Massachusetts, Worcester

Status: Begins enrollment in 7 months

Conditions: Safe Sleep Education; SUID; Sudden Infant Death Syndrome (SIDS)

Treatments: Behavioral: Safe Sleep TodaysNICUBaby videos and messages; Behavioral: Safe Sleep NICU Quality Improvement Campaign; Behavioral: Shared Reading TodaysNICUBaby videos and messages; Behavioral: Shared Reading NICU Quality Improvement Campaign

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07420686

2R01HD095060-06 (U.S. NIH Grant/Contract)

STUDY00002732

Details and patient eligibility

About

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.

Enrollment: 1,600 estimated patients

Sex: Female

Ages: 13+ years old

Volunteers: 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,600 participants in 4 patient groups

Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages

Experimental group

Treatment:

Behavioral: Shared Reading TodaysNICUBaby videos and messages

Behavioral: Safe Sleep NICU Quality Improvement Campaign

Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages

Experimental group

Treatment:

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 group

Treatment:

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 group

Treatment:

Behavioral: Shared Reading NICU Quality Improvement Campaign

Behavioral: Shared Reading TodaysNICUBaby videos and messages