Safe Sleep Education, Sudden Infant Death Syndrome (SIDS), SUID
Conditions
Brief 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.
Interventions
BEHAVIORALSafe 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.
BEHAVIORALShared 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.
BEHAVIORALSafe 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.
BEHAVIORALShared 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
University of Massachusetts, Worcester
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
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of the NICU safe sleep intervention on safe infant sleep position | 60 days post-discharge | Percent with exclusive supine sleep in the previous 2 weeks |
| Impact of the NICU safe sleep intervention on safe infant sleep location | 60 days post-discharge | Percent with exclusive room sharing without bedsharing in the previous 2 weeks |
| Impact of the NICU safe sleep intervention safe sleep space | 60 days post-discharge | 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.) |
| Impact of the NICU safe sleep intervention on safe infant sleep environment | 60 days post-discharge | Percent with absence of loose objects in the sleep area in the previous 2 weeks |
| Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep position | 60 days post-discharge | Percent with exclusive supine sleep in the previous 2 weeks |
| Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep location | 60 days post-discharge | Percent with exclusive room sharing without bedsharing in the previous 2 weeks |
| Impact of the mHealth post-discharge safe sleep intervention safe sleep space | 60 days post-discharge | 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.) |
| Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep environment | 60 days post-discharge | Percent with absence of loose objects in the sleep area in the previous 2 weeks |
| Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep position | 60 days post-discharge | Percent with exclusive supine sleep in the previous 2 weeks |
| Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep location | 60 days post-discharge | Percent with exclusive room sharing without bedsharing in the previous 2 weeks |
| Impact of the NICU and mHealth post-discharge safe sleep intervention safe sleep space | 60 days post-discharge | 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.) |
| Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep environment | 60 days post-discharge | Percent with absence of loose objects in the sleep area in the previous 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of the NICU shared reading intervention on reading | 60 days post-discharge | Score on the READ scale of the STIM-Q |
| Impact of the post-discharge mHealth shared reding intervention on reading | 60 days post-discharge | Score on the READ scale of the STIM-Q |
| Impact on the NICU and post-discharge mHealth shared reading interventions on reading | 60 days post-discharge | Score on the READ scale of the STIM-Q |
| Impact of the NICU shared reading intervention on early relational health | 60 days post-discharge | Score on the post-partum bonding questionnaire |
| Impact of the post-discharge mHealth shared reding intervention on early relational health | 60 days post-discharge | Score on the post-partum bonding questionnaire |
| Impact on the NICU and post-discharge mHealth shared reading interventions on early relational health | 60 days post-discharge | Score on the post-partum bonding questionnaire |
| Reading by maternal race/ethnicity | 60 days post-discharge | Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic) |
| Early relational health by race/ethnicity | 60 days post-discharge | Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic) |
| Reading by infant gestational age | 60 days post-discharge | Score on the post-partum bonding questionnaire by infant gestational age ( \<29 weeks vs 29-36 weeks) |
| Early relational health by infant gestational age | 60 days post-discharge | Score on the post-partum bonding questionnaire by infant gestational age (\<29 weeks vs 29-36 weeks) |
| Feasibility of NICU interventions | In year 4-5 of study period, after completion of enrollment on subjects | Mean score reported by NICU staff on the Feasibility of Intervention Measure (FIM), a 4-item measure of perceived intervention feasibility |
| Acceptability of NICU interventions | In year 4-5 of study period, after completion of enrollment on subjects | Mean score reported by NICU staff on the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability. Scores are calculated as the mean |
| Fidelity to NICU safe sleep intervention | Baseline | Percentage of mothers reporting observed modeling of safe sleep practices (supine sleep position and absence of objects in the sleep environment) and receipt of safe sleep education while in the NICU |
| Fidelity to NICU shared reading intervention | Baseline | Percentage of mothers reporting participation in shared reading and receipt of shared reading education while in the NICU |
| Fidelity to mHealth interventions | Days 1-60 post-discharge | Percentage of videos opened by mothers as a proxy for videos watched |
| Impact of the mHealth post-discharge sleep intervention on intention for safe infant sleep position | 60 days post-discharge | Percent with intention for exclusive supine sleep after NICU discharge |
| Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep location | 60 days post-discharge | Percent with intention for exclusive room sharing without bedsharing after NICU discharge |
| Safe infant sleep position by maternal race/ethnicity | 60 days post-discharge | Percent with exclusive supine sleep in the previous 2 weeks, by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic) |
| Safe infant sleep location by maternal race/ethnicit | 60 days post-discharge | Percent with exclusive room sharing without bedsharing in the previous 2 weeks by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic) |
| Safe sleep space by maternal race/ethnicity | 60 days post-discharge | 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) |
| Safe infant sleep environment by maternal race/ethnicity | 60 days post-discharge | 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) |
| Safe infant sleep position by infant gestational age | 60 days post-discharge | Percent with exclusive supine sleep in the previous 2 weeks, by infant gestational age (\<29 weeks vs 29-36 weeks) |
| Safe infant sleep location by infant gestational age | 60 days post-discharge | Percent with exclusive room sharing without bedsharing in the previous 2 weeks infant gestational age (\<29 weeks vs 29-36 weeks) |
| Safe sleep space by infant gestational age | 60 days post-discharge | 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.) infant gestational age (\<29 weeks vs 29-36 weeks) |
| Safe infant sleep environment by infant gestational age | 60 days post-discharge | Percent with absence of loose objects in the sleep space in the previous 2 weeks by infant gestational age (\<29 weeks vs 29-36 weeks) |
| Impact of the NICU safe sleep intervention on intention for safe infant sleep position | Baseline and 60 days post-discharge | Percent with intention for exclusive supine sleep after NICU discharge |
| Impact of the NICU safe sleep intervention on intention for safe infant sleep location | Baseline and 60 days post-discharge | Percent with intention for exclusive room sharing without bedsharing after NICU discharge |
| Impact of the NICU safe sleep intervention on intention for safe infant safe sleep space | Baseline and 60 days post-discharge | Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.) |
| Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space | 60 days post-discharge | Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.) |
| Impact of the NICU safe sleep intervention on intention for safe infant sleep environment | Baseline and 60 days post-discharge | Percent with intention for no loose objects in the sleep area after NICU discharge |
| Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment | 60 days post-discharge | Percent with intention for no loose objects in the sleep area after NICU discharge |
| Impact of the NICU and mHealth post-discharge sleep intervention on intention for safe infant sleep position | 60 days post-discharge | Percent with intention for exclusive supine sleep after NICU discharge |
| Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep location | 60 days post-discharge | Percent with intention for exclusive room sharing without bedsharing after NICU discharge |
| Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space | 60 days post-discharge | Percent with intention for exclusive sleep in a crib/bassinet after NICU discharge (and no sleep in another sleep space- swing, car seat, boppy, adult bed, etc.) |
| Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment | 60 days post-discharge | Percent with intention for no loose objects in the sleep area after NICU discharge |
| Impact of the NICU safe sleep intervention on time to unsafe sleep position | 0 to 60 days post-discharge | Time to place infant in an unsafe sleep position (any side or prone) |
| Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep position | 0 to 60 days post-discharge | Time to place infant in an unsafe sleep position (any side or prone) |
| Impact of the NICU and mHealth post-discharge safe sleep intervention on time to unsafe sleep position | 0 to 60 days post-discharge | Time to place infant in an unsafe sleep position (any side or prone) |
| Impact of the NICU safe sleep intervention on time to unsafe sleep location | 0 to 60 days post-discharge | Time to place infant in an unsafe sleep location (any bedsharing) |
| Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep location | 0 to 60 days post-discharge | Time to place infant in an unsafe sleep location (any bedsharing) |
| Impact of the NICU and mHealth post-discharge safe sleep intervention on unsafe sleep location | 0 to 60 days post-discharge | Time to place infant in an unsafe sleep location (any bedsharing) |
Countries
United States
Contacts
CONTACTMargaret Parker, MD, MPH
CONTACTMayra Rojas, BS
Outcome results
None listed