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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01HD095060-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| Boston Medical Center | OTHER |
| Boston University | OTHER |
| University of Virginia |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safe Sleep NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messages | Experimental |
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| Shared Reading NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages | Experimental |
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| Safe Sleep NICU Quality Improvement Campaign and Safe Sleep TodaysNICUBaby videos and messages | Experimental |
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| Shared Reading NICU Quality Improvement Campaign and Shared Reading TodaysNICUBaby videos and messag | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the NICU safe sleep intervention on safe infant sleep position | Percent with exclusive supine sleep in the previous 2 weeks | 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 | 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.) | 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 | 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 | 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 | 60 days post-discharge |
| Impact of the mHealth post-discharge safe sleep intervention safe sleep space |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 60 days post-discharge |
| Safe infant sleep location by maternal race/ethnicit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret Parker, MD, MPH | Contact | 5083343180 | Margaret.Parker@umassmemorial.org | |
| Mayra Rojas, BS | Contact | 5083343180 | mayra.rojascorrea@umassmed.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01545 | United States |
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| OTHER |
| New York University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Colorado, Denver | OTHER |
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| Shared Reading NICU Quality Improvement Campaign | Behavioral | We will train NICU staff working in hospitals randomized to the shared reading intervention to:
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| Safe Sleep TodaysNICUBaby videos and messages | Behavioral | The TodaysNICUBaby mHealth program is comprised of:
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| Shared Reading TodaysNICUBaby videos and messages | Behavioral | The Shared Reading TodaysNICUBaby mHealth program is comprised of:
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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.)
| 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 | 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 | 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 | 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.) | 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 | 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) |
| 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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.) | 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 | 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 | 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 | 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.) | 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 | 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 | 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 | 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.) | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 0 to 60 days post-discharge |
| Impact of the NICU shared reading intervention on reading | Score on the READ scale of the STIM-Q | 60 days post-discharge |
| Impact of the post-discharge mHealth shared reding intervention on reading | Score on the READ scale of the STIM-Q | 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 | 60 days post-discharge |
| Impact of the NICU shared reading intervention on early relational health | Score on the post-partum bonding questionnaire | 60 days post-discharge |
| Impact of the post-discharge mHealth shared reding intervention on early relational health | Score on the post-partum bonding questionnaire | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | Baseline |
| Fidelity to mHealth interventions | Percentage of videos opened by mothers as a proxy for videos watched | Days 1-60 post-discharge |
| ID | Term |
|---|---|
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D066088 | Infant Death |
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