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Not Applicable

Not yet recruiting

• Conditions: Infant Death; Sudden Infant Death
• Interventions: Behavioral: TodaysBaby

• Registration Number: NCT06618586
• Lead Sponsor: University of Virginia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Study Start: 2025-05
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10000

Inclusion Criteria

• 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

Exclusion Criteria

• A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
New low touch (LT) hospital implementation strategy	TodaysBaby	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.
Original high touch (HT) hospital implementation strategy	TodaysBaby	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.

Primary Outcome Measures

Name	Time	Method
Penetration of sign up for TodaysBaby	First week after birth	Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies
Equity of sign up for TodaysBaby	First week after birth	Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies

Secondary Outcome Measures

Name	Time	Method
Feasibility of implementation	Within a year of participant enrollment (qualitative) and >60 day after birth survey	Staff perception that the implementation strategies were successfully used or carried out (measured through semi-structured interviews; Rate of maternal report that signing up for TodaysBaby was simple and fast
Acceptability	Within a year of participant enrollment	Staff perception that the delivery of the implementation strategies was satisfactory (measured through semi-structured interviews)
Sustainability	Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods	Staff perception that the implementation strategies could continue to be delivered after the end of the study (measured through semi-structured interviews); monthly penetration rates
Fidelity	First 60 days after birth	Number of videos viewed by mother, divided by total videos among mothers enrolled in the different implementation strategies
Effectiveness of TodaysBaby on safe sleep practices	60-180 days (average 80 days) after birth survey	We will measure 4 sleep practices in the past 2 weeks among mothers enrolled in the different implementation strategies: Sleep position: % reporting supine position only Sleep location: % reporting roomsharing not bedsharing only Soft bedding: % reporting no soft bedding in sleep space Pacifier: % reporting usual pacifier use when infant sleeping
Program cost of TodaysBaby	60-180 days during the program sign up periods.	Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies