Social Media and Risk-reduction Training for Preterm Infant Care Practices
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age13+
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Factorial
Treatments tested in this trial
Safe Sleep NICU Quality Improvement Campaign
BehavioralWe 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
BehavioralWe 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
BehavioralThe 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
BehavioralThe 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.
Treatment groups
1,600 Participants
are divided into 4 treatment groupsGroup A: Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messagesExperimental treatment 2 interventions
Group B: Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messagesExperimental treatment 2 interventions
Group C: Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messagesExperimental treatment 2 interventions
Group D: Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messagOther 2 interventions
Trial outcomes
Primary outcomes
1
Impact of the NICU safe sleep intervention on safe infant sleep position
Percent with exclusive supine sleep in the previous 2 weeks
Time frame
60 days post-discharge2
Impact of the NICU safe sleep intervention on safe infant sleep location
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
Time frame
60 days post-discharge3
Impact of the NICU safe sleep intervention safe sleep space
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.)
Time frame
60 days post-discharge4
Impact of the NICU safe sleep intervention on safe infant sleep environment
Percent with absence of loose objects in the sleep area in the previous 2 weeks
Time frame
60 days post-dischargeSecondary outcomes
1
Safe infant sleep position by maternal race/ethnicity
Percent with exclusive supine sleep in the previous 2 weeks, by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)
Time frame
60 days post-discharge2
Safe infant sleep location by maternal race/ethnicit
Percent with exclusive room sharing without bedsharing in the previous 2 weeks by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)
Time frame
60 days post-discharge3
Safe sleep space by maternal race/ethnicity
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)
Time frame
60 days post-discharge4
Safe infant sleep environment by maternal race/ethnicity
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)
Time frame
60 days post-dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
Washington University School of Medicine
Collaborator
Boston Medical Center
Collaborator
Boston University
Collaborator
University of Virginia
Collaborator
New York University
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov
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