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

Summary

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.

Conditions

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

Interventions

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 NICU Quality Improvement Campaign

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.

BEHAVIORAL

Safe Sleep TodaysNICUBaby videos and messages

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.

BEHAVIORAL

Shared Reading TodaysNICUBaby videos and messages

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.

Sponsors & Collaborators

• Washington University School of Medicine

  collaborator OTHER

• Boston Medical Center

  collaborator OTHER

• Boston University

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• New York University

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Colorado, Denver

  collaborator OTHER

• University of Massachusetts, Worcester

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

13 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2027-01-01

Primary Completion

2028-06-30

Completion

2028-12-31

Countries

• United States

Study Locations