Recruiting

TodaysBaby™

Sponsor:

University of Virginia

Code:

NCT06618586

Conditions

Infant Death

Sudden Infant Death

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

TodaysBaby

Study Details

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.

Conditions

Infant Death

Sudden Infant Death

Study ID

NCT06618586

Start date

May 1, 2025

Status verified date

Jun, 2025

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

10000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

TodaysBaby

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 .

Primary outcome measure

  • Penetration of sign up for TodaysBaby [ Time Frame: First week after birth ]
  • Equity of sign up for TodaysBaby [ Time Frame: First week after birth ]

Central Contacts and Locations

Central contacts

Locations

Boston University

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

More Information

Sponsor

University of Virginia

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • Safe Sleep
  • Mobile Messaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-06-11.