TodaysBaby for Sudden Infant Death Syndrome

(GETSMART Trial)

Overseen By Sarah Roth, MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Prenatal diagnosis impacting infant care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rachel Y Moon, MD

Principal Investigator

University of Virginia School of Medicine

Eligibility Criteria

This trial is for individuals in the United States who are planning to care for a newborn and live with them. Participants must have given birth to a healthy, full-term infant (37 weeks or more) and be discharged within 7 days of birth. They need to enroll in the TodaysBaby program by the time their baby is 7 days old.

Inclusion Criteria

I live in the United States.

I recently gave birth to a full-term, healthy baby.

I plan to care for my baby and live with them after birth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 months

1 visit (in-person)

Intervention

Implementation of TodaysBaby™ mobile safe sleep intervention program with high touch and low touch strategies

6 months

Ongoing interaction through mobile app

Control

Standard postpartum care with survey completion regarding infant care practices

3 months

1 visit (in-person)

Follow-up

Participants are monitored for effectiveness of the intervention on safe sleep practices

60-180 days

Surveys conducted

Treatment Details

Interventions

• TodaysBaby

Trial Overview The study tests the TodaysBaby™ mobile app intervention designed to promote safe sleep practices in infants, aiming to reduce risks associated with sudden infant death syndrome. It will evaluate how well the program works across different income levels and racial/ethnic groups.

Participant Groups

Group I: New low touch (LT) hospital implementation strategy Experimental Treatment 1 Intervention

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.

Group II: Original high touch (HT) hospital implementation strategy Active Control 1 Intervention

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.

Group III: Control- Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+