An interventional study of TodaysBaby in Infant Death and Sudden Infant Death, sponsored by University of Virginia. Recruiting at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by University of Virginia · Not applicable, Interventional, and Health services research
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.
80 studies on the registry are indexed under Sudden Infant Death; 14 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 60 across 51 interventional studies indexed under Sudden Infant Death.
Browse Sudden Infant Death studies →University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
Compared within Sudden Infant Death, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infant Death. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Behavioral: 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.
Behavioral: TodaysBaby
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.
The TodaysBaby intervention is comprised of: 1) Text message-delivered, short educational videos in the first 2 months after birth, with each video timed to match content addressing anticipated barriers and facilitators to adhering to guidelines (e.g. parental concerns that infant will choke while supine). Participants will also have access to a web portal where intervention videos will be maintained. 2) Text queries regarding safe sleep practices, which collect data on sleep practices in near real-time and provide reinforcement of adherence. Mothers will receive 1-2 text message questions weekly that assess sleep practices in near real-time .
Penetration of sign up for TodaysBaby
Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies
Time frame: First week after birth
Equity of sign up for TodaysBaby
Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies
Time frame: First week after birth
Feasibility of implementation
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
Time frame: Within a year of participant enrollment (qualitative) and >60 day after birth survey
Acceptability
Staff perception that the delivery of the implementation strategies was satisfactory (measured through semi-structured interviews)
Time frame: Within a year of participant enrollment
Sustainability
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
Time frame: Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods
Fidelity
Number of videos viewed by mother, divided by total videos among mothers enrolled in the different implementation strategies
Time frame: First 60 days after birth
Effectiveness of TodaysBaby on safe sleep practices
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
Time frame: 60-180 days (average 80 days) after birth survey
Program cost of TodaysBaby
Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies
Time frame: 60-180 days during the program sign up periods.
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Jun 2027, 25 months after the start.
Of 15 interventional studies with no phase under Sudden Infant Death, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 25 months is above that.
How these figures are worked out, and which studies are left out of them.
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