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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile program called TodaysBaby, aimed at preventing Sudden Infant Death Syndrome (SIDS) by promoting safe sleep practices for newborns. It compares different methods of introducing the program in hospitals to determine which is most effective and accepted by new parents. The trial targets mothers who have recently given birth to a healthy, full-term baby, plan to live with and care for their baby, and can enroll in the program within a week of birth. Participants will either receive assistance from hospital staff to enroll or sign up independently using a QR code. The goal is to assess the program's implementation and effectiveness in promoting safe sleep. As an unphased trial, this study allows participants to contribute to important research that could enhance newborn safety practices.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the TodaysBaby program is safe for infants?

Research has shown that the TodaysBaby™ mobile app is designed to improve infant sleep safety. Although specific negative effects from using this program have not been reported, it aims to encourage safer sleep habits, which should help lower the risk of sudden infant death syndrome (SIDS) and other sleep-related issues.

The program's main purpose is to educate and provide resources. It does not involve medications or physical treatments, which typically raise more safety concerns, making it generally low-risk for participants. Since the trial is not in a specific testing phase, it likely focuses on the program's effectiveness rather than safety testing, suggesting minimal risks primarily related to app usage and adherence to its guidance.

Overall, the TodaysBaby™ program appears well-received, with no current reports of negative effects. Participants will likely find it safe as it aims to support better infant care practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TodaysBaby trial for Sudden Infant Death Syndrome (SIDS) because it explores innovative approaches to engaging new mothers in infant care education. Unlike traditional methods that rely on standard postpartum care and general guidelines, TodaysBaby uses two unique strategies: a high-touch method, where hospital staff engage directly with mothers, and a low-touch method, where mothers self-enroll using a QR code. These strategies aim to enhance the accessibility and personalization of infant care education, potentially leading to better awareness and preventive practices against SIDS. By integrating technology and direct consumer marketing, this trial could unveil more effective ways to deliver crucial health information to new parents.

What evidence suggests that the TodaysBaby program is effective for reducing Sudden Infant Death Syndrome?

Research shows that sudden infant death syndrome (SIDS) is a major cause of infant deaths, with about 1,529 cases in the U.S. in 2022. Most sudden unexpected infant deaths (SUID) result from unsafe sleep practices. The TodaysBaby program, which trial participants may experience through various hospital implementation strategies, focuses on promoting safe sleep habits, crucial for reducing SIDS risk. Studies have found that teaching safe sleep practices along with breastfeeding support can enhance infant safety. The TodaysBaby program aims to improve these practices by providing new parents with easy access to information and support, potentially lowering the risk of SIDS. ^{2 6 7 8 9}

Who Is on the Research Team?

Rachel Y Moon, MD

Principal Investigator

University of Virginia School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12234550/

Global, regional, and national burden of sudden infant death ... In 2021, global SIDS deaths totaled 30,608, with a mortality rate of 24.16 per 100,000 infants (95% UI, 14.06–32.44). Global DALYs were ...

2. cdc.gov cdc.gov/sudden-infant-death/data-research/data/index.html

Data and Statistics for SUID and SIDS In 2022, there were about 3,700 sudden unexpected infant deaths (SUID) in the United States. There were: 1,529 deaths from SIDS. 1,131 deaths ...

3. publications.aap.org publications.aap.org/pediatrics/article/151/4/e2022058820/190834/Sudden-Unexpected-Infant-Deaths-2015-2020

Sudden Unexpected Infant Deaths: 2015–2020 | Pediatrics United States infant mortality reached a record low in 2020. The sudden infant death syndrome (SIDS) rate increased 15% from 2019 to 2020.

4. pediatrics.jmir.org pediatrics.jmir.org/2025/1/e65247

Integrating Infant Safe Sleep and Breastfeeding Education Into ... Sudden unexpected infant death (SUID) is a leading cause of death among US infants, with nonrecommended sleep practices reported in most of ...

5. nationwidechildrens.org nationwidechildrens.org/family-resources-education/700childrens/2022/08/new-sids-research

New Research on Sudden Infant Death Syndrome (SIDS) The results demonstrated that those infants who died from SIDS had statistically significant decreased BChE activity level when compared to the ...

6. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2831719

Study Finds Sleep-Related Infant Deaths Are on the Rise In 2018 through 2022, the SUID rate per 100 000 births ranged from a low of 22 among Asian infants to a high of 238 for Black infants. Even more ...

7. publications.aap.org publications.aap.org/pediatrics/article/150/1/e2022057990/188304/Sleep-Related-Infant-Deaths-Updated-2022

Sleep-Related Infant Deaths: Updated 2022 ... The American Academy of Pediatrics recommends a safe sleep environment to reduce the risk of all sleep-related deaths.

8. nichd.nih.gov nichd.nih.gov/health/topics/sids/conditioninfo/risk

How many infants die from SIDS or are at risk for SIDS? | NICHD Data from the Centers for Disease Control and Prevention (CDC) estimate that about 3,000 infants died from a sudden unexpected infant death, ...

9. hopkinsmedicine.org hopkinsmedicine.org/news/newsroom/news-releases/2025/10/sleep-practices-during-infant-illnesses-may-increase-risk-of-sudden-infant-death

Sleep Practices During Infant Illnesses May Increase Risk ... SUID, defined as the unexpected sudden death of a seemingly healthy infant from known and unknown causes, resulted in the deaths of 3,700 ...