Sudden Infant Death Syndrome (SIDS) Clinical Trials

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Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• Must speak English or Spanish

• Must live in the United States

• Must have given birth to a healthy, term infants (37 weeks or greater) and be discharged within 7 days of birth

• Must plan to care for infant and live in the same household as infant after birth

• Must enroll in the TodaysBaby program by the time their infant is 7 days of age

Locations
United States
Massachusetts
Boston University
RECRUITING
Boston
Contact Information
Primary
Sarah Roth, MPH
saroth@bu.edu
(617)206-6198
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 10000
Treatments
Experimental: New low touch (LT) hospital implementation strategy
This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm mothers will be attracted to TodaysBaby through direct-to-consumer marketing and sign themselves up using a QR code. These mothers will also receive standard postpartum care.
Active_comparator: Original high touch (HT) hospital implementation strategy
This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm hospital staff will help mothers sign up and view the first 2 TodaysBaby in a one-on-one conversation format. These mothers will also receive standard postpartum care.
No_intervention: Control- Standard of Care
During the 3 months immediately prior to the first intervention time period, hospitals will recruit approximately 100 mothers to complete surveys regarding infant care practices. These mothers will also receive postpartum standard of care.
Related Therapeutic Areas
Sponsors
Collaborators: Washington University School of Medicine, Columbia University, Boston Medical Center, Boston University, University of Massachusetts, Worcester, University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: University of Virginia

This content was sourced from clinicaltrials.gov