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

Conditions

• SUID
• Safe Sleep Education
• Sudden Infant Death Syndrome (SIDS)

Eligibility Criteria

Sex

FEMALE

Age

13 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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: 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.
• Safe Sleep TodaysNICUBaby videos and messages — BEHAVIORAL
  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.
• Shared Reading TodaysNICUBaby videos and messages — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Jan 1, 2027

Status verified

Feb 2026

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

1,600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Arms

• Experimental: Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages
• Experimental: Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
• Experimental: Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
• Other: Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag

Primary Outcome Measure

Impact of the NICU safe sleep intervention on safe infant sleep position [ Time Frame: 60 days post-discharge ]

Central Contacts

• Margaret Parker, MD, MPH
  5083343180
  [email protected]
• Mayra Rojas, BS
  5083343180
  [email protected]

Locations (1)

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