Safe Sleep EducationSMART PreemieNCT07420686
Social Media and Risk-reduction Training for Preterm Infant Care Practices
A study testing Safe Sleep NICU Quality Improvement Campaign, Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages in people with Safe Sleep Education and SUID, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Safe Sleep Education, SUID, Sudden Infant Death Syndrome (SIDS)
- What is being tested?
- Safe Sleep NICU Quality Improvement Campaign, Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01545
Mayra Rojas, 5083346180, mayra.rojascorrea@umassmed.edu
About this study
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.
- Being tested
- Safe Sleep NICU Quality Improvement Campaign, Shared Reading NICU Quality Improvement Campaign, Safe Sleep TodaysNICUBaby videos and messages, Shared Reading TodaysNICUBaby videos and messages
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Sleep NICU Quality Improvement CampaignBehavioural
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 CampaignBehavioural
We will train NICU staff working in hospitals randomized to the shared reading intervention to:
- Model shared reading practices with book distribution, and
- 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 messagesBehavioural
The TodaysNICUBaby mHealth program is comprised of:
- text message-delivered, short educational videos in the first 8 weeks after NICU discharge and
- 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 messagesBehavioural
The Shared Reading TodaysNICUBaby mHealth program is comprised of:
- text message-delivered, short educational videos in the first 8 weeks after NICU discharge and
- text queries regarding shared reading, which collect data on these practices in near real-time and provide reinforcement of adherence.
| Study group | Role | What they receive |
|---|---|---|
| Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages | Experimental | Not described Receives: Behavioral: Safe Sleep NICU Quality Improvement Campaign; Behavioral: Shared Reading TodaysNICUBaby videos and messages |
| Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages | Experimental | Not described Receives: 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 | Not described Receives: 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 | Not described Receives: Behavioral: Shared Reading NICU Quality Improvement Campaign; Behavioral: Shared Reading TodaysNICUBaby videos and messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the NICU safe sleep intervention on safe infant sleep position
Percent with exclusive supine sleep in the previous 2 weeks
Measured: 60 days post-discharge
Impact of the NICU safe sleep intervention on safe infant sleep location
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
Measured: 60 days post-discharge
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.)
Measured: 60 days post-discharge
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
Measured: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep position
Percent with exclusive supine sleep in the previous 2 weeks
Measured: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep location
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
Measured: 60 days post-discharge
Impact of the mHealth post-discharge 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.)
Measured: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on safe infant sleep environment
Percent with absence of loose objects in the sleep area in the previous 2 weeks
Measured: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep position
Percent with exclusive supine sleep in the previous 2 weeks
Measured: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep location
Percent with exclusive room sharing without bedsharing in the previous 2 weeks
Measured: 60 days post-discharge
Impact of the NICU and mHealth post-discharge 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.)
Measured: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on safe infant sleep environment
Percent with absence of loose objects in the sleep area in the previous 2 weeks
Measured: 60 days post-discharge
Secondary outcomes (41)
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)
Measured: 60 days post-discharge
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)
Measured: 60 days post-discharge
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)
Measured: 60 days post-discharge
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)
Measured: 60 days post-discharge
Safe infant sleep position by infant gestational age
Percent with exclusive supine sleep in the previous 2 weeks, by infant gestational age (<29 weeks vs 29-36 weeks)
Measured: 60 days post-discharge
Safe infant sleep location by infant gestational age
Percent with exclusive room sharing without bedsharing in the previous 2 weeks infant gestational age (<29 weeks vs 29-36 weeks)
Measured: 60 days post-discharge
Safe sleep space by infant gestational age
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)
Measured: 60 days post-discharge
Safe infant sleep environment by infant gestational age
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)
Measured: 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep position
Percent with intention for exclusive supine sleep after NICU discharge
Measured: Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep location
Percent with intention for exclusive room sharing without bedsharing after NICU discharge
Measured: Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant safe sleep space
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.)
Measured: Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep environment
Percent with intention for no loose objects in the sleep area after NICU discharge
Measured: Baseline and 60 days post-discharge
Impact of the mHealth post-discharge sleep intervention on intention for safe infant sleep position
Percent with intention for exclusive supine sleep after NICU discharge
Measured: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep location
Percent with intention for exclusive room sharing without bedsharing after NICU discharge
Measured: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space
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.)
Measured: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment
Percent with intention for no loose objects in the sleep area after NICU discharge
Measured: 60 days post-discharge
Impact of the NICU and mHealth post-discharge sleep intervention on intention for safe infant sleep position
Percent with intention for exclusive supine sleep after NICU discharge
Measured: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep location
Percent with intention for exclusive room sharing without bedsharing after NICU discharge
Measured: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space
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.)
Measured: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment
Percent with intention for no loose objects in the sleep area after NICU discharge
Measured: 60 days post-discharge
Impact of the NICU safe sleep intervention on time to unsafe sleep position
Time to place infant in an unsafe sleep position (any side or prone)
Measured: 0 to 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep position
Time to place infant in an unsafe sleep position (any side or prone)
Measured: 0 to 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on time to unsafe sleep position
Time to place infant in an unsafe sleep position (any side or prone)
Measured: 0 to 60 days post-discharge
Impact of the NICU safe sleep intervention on time to unsafe sleep location
Time to place infant in an unsafe sleep location (any bedsharing)
Measured: 0 to 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep location
Time to place infant in an unsafe sleep location (any bedsharing)
Measured: 0 to 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on unsafe sleep location
Time to place infant in an unsafe sleep location (any bedsharing)
Measured: 0 to 60 days post-discharge
Impact of the NICU shared reading intervention on reading
Score on the READ scale of the STIM-Q
Measured: 60 days post-discharge
Impact of the post-discharge mHealth shared reding intervention on reading
Score on the READ scale of the STIM-Q
Measured: 60 days post-discharge
Impact on the NICU and post-discharge mHealth shared reading interventions on reading
Score on the READ scale of the STIM-Q
Measured: 60 days post-discharge
Impact of the NICU shared reading intervention on early relational health
Score on the post-partum bonding questionnaire
Measured: 60 days post-discharge
Impact of the post-discharge mHealth shared reding intervention on early relational health
Score on the post-partum bonding questionnaire
Measured: 60 days post-discharge
Impact on the NICU and post-discharge mHealth shared reading interventions on early relational health
Score on the post-partum bonding questionnaire
Measured: 60 days post-discharge
Reading by maternal race/ethnicity
Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)
Measured: 60 days post-discharge
Early relational health by race/ethnicity
Score on the READ scale of the STIM-Q by maternal race (Black, White, Other) and ethnicity (Hispanic vs. non-Hispanic)
Measured: 60 days post-discharge
Reading by infant gestational age
Score on the post-partum bonding questionnaire by infant gestational age ( <29 weeks vs 29-36 weeks)
Measured: 60 days post-discharge
Early relational health by infant gestational age
Score on the post-partum bonding questionnaire by infant gestational age (<29 weeks vs 29-36 weeks)
Measured: 60 days post-discharge
Feasibility of NICU interventions
Mean score reported by NICU staff on the Feasibility of Intervention Measure (FIM), a 4-item measure of perceived intervention feasibility
Measured: In year 4-5 of study period, after completion of enrollment on subjects
Acceptability of NICU interventions
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
Measured: In year 4-5 of study period, after completion of enrollment on subjects
Fidelity to NICU safe sleep intervention
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
Measured: Baseline
Fidelity to NICU shared reading intervention
Percentage of mothers reporting participation in shared reading and receipt of shared reading education while in the NICU
Measured: Baseline
Fidelity to mHealth interventions
Percentage of videos opened by mothers as a proxy for videos watched
Measured: Days 1-60 post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safe Sleep EducationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Margaret Parker, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420686
- Sponsor's protocol ID
- STUDY00002732
- Other IDs
- 2R01HD095060-06
- Acronym
- SMART Preemie
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Media and Risk-reduction Training for Preterm Infant Care Practices
- ClinicalTrials.gov ID
- NCT07420686
- Acronym / sponsor ID
- SMART Preemie / STUDY00002732
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- 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 start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages | Experimental | Behavioral: Safe Sleep NICU Quality Improvement Campaign, Behavioral: Shared Reading TodaysNICUBaby videos and messages |
| Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages | Experimental | 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 | 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 | Behavioral: Shared Reading NICU Quality Improvement Campaign, Behavioral: Shared Reading TodaysNICUBaby videos and messages |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Sleep NICU Quality Improvement CampaignWe 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. | Behavioural | Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages, Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages |
| Shared Reading NICU Quality Improvement CampaignWe 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. | Behavioural | Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages, Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag |
| Safe Sleep TodaysNICUBaby videos and messagesThe 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. | Behavioural | Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages, Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages |
| Shared Reading TodaysNICUBaby videos and messagesThe 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. | Behavioural | Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages, Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag |
Primary outcome
Impact of the NICU safe sleep intervention on safe infant sleep position
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 60 days post-discharge
Percent with absence of loose objects in the sleep area in the previous 2 weeks
41 secondary outcomes
Safe infant sleep position by maternal race/ethnicity
Time frame: 60 days post-discharge
Safe infant sleep location by maternal race/ethnicit
Time frame: 60 days post-discharge
Safe sleep space by maternal race/ethnicity
Time frame: 60 days post-discharge
Safe infant sleep environment by maternal race/ethnicity
Time frame: 60 days post-discharge
Safe infant sleep position by infant gestational age
Time frame: 60 days post-discharge
Safe infant sleep location by infant gestational age
Time frame: 60 days post-discharge
Safe sleep space by infant gestational age
Time frame: 60 days post-discharge
Safe infant sleep environment by infant gestational age
Time frame: 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep position
Time frame: Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep location
Time frame: Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant safe sleep space
Time frame: Baseline and 60 days post-discharge
Impact of the NICU safe sleep intervention on intention for safe infant sleep environment
Time frame: Baseline and 60 days post-discharge
Impact of the mHealth post-discharge sleep intervention on intention for safe infant sleep position
Time frame: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep location
Time frame: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space
Time frame: 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment
Time frame: 60 days post-discharge
Impact of the NICU and mHealth post-discharge sleep intervention on intention for safe infant sleep position
Time frame: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep location
Time frame: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant safe sleep space
Time frame: 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on intention for safe infant sleep environment
Time frame: 60 days post-discharge
Impact of the NICU safe sleep intervention on time to unsafe sleep position
Time frame: 0 to 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep position
Time frame: 0 to 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on time to unsafe sleep position
Time frame: 0 to 60 days post-discharge
Impact of the NICU safe sleep intervention on time to unsafe sleep location
Time frame: 0 to 60 days post-discharge
Impact of the mHealth post-discharge safe sleep intervention on time to unsafe sleep location
Time frame: 0 to 60 days post-discharge
Impact of the NICU and mHealth post-discharge safe sleep intervention on unsafe sleep location
Time frame: 0 to 60 days post-discharge
Impact of the NICU shared reading intervention on reading
Time frame: 60 days post-discharge
Impact of the post-discharge mHealth shared reding intervention on reading
Time frame: 60 days post-discharge
Impact on the NICU and post-discharge mHealth shared reading interventions on reading
Time frame: 60 days post-discharge
Impact of the NICU shared reading intervention on early relational health
Time frame: 60 days post-discharge
Impact of the post-discharge mHealth shared reding intervention on early relational health
Time frame: 60 days post-discharge
Impact on the NICU and post-discharge mHealth shared reading interventions on early relational health
Time frame: 60 days post-discharge
Reading by maternal race/ethnicity
Time frame: 60 days post-discharge
Early relational health by race/ethnicity
Time frame: 60 days post-discharge
Reading by infant gestational age
Time frame: 60 days post-discharge
Early relational health by infant gestational age
Time frame: 60 days post-discharge
Feasibility of NICU interventions
Time frame: In year 4-5 of study period, after completion of enrollment on subjects
Acceptability of NICU interventions
Time frame: In year 4-5 of study period, after completion of enrollment on subjects
Fidelity to NICU safe sleep intervention
Time frame: Baseline
Fidelity to NICU shared reading intervention
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
Related trials for Safe Sleep Education
Not yet recruiting
Animation-Supported Infant Sleep Safety Education
Infant Sleep Safety
Not yet recruiting
The Impact of the Nurse-Led "My Baby is Safe" Educational Program
Sudden Infant Death Syndrome, Shaken Baby Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Sleep NICU Quality Improvement Campaign, Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages in people with Safe Sleep Education and SUID, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaret Parker, MD, MPH (5083343180, Margaret.Parker@umassmemorial.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the NICU safe sleep intervention on safe infant sleep position (time frame: 60 days post-discharge). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.