TodaysBaby for Sudden Infant Death Syndrome
(GETSMART Trial)
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.12345Why 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.26789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Implementation of TodaysBaby™ mobile safe sleep intervention program with high touch and low touch strategies
Control
Standard postpartum care with survey completion regarding infant care practices
Follow-up
Participants are monitored for effectiveness of the intervention on safe sleep practices
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?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
Boston Medical Center
Collaborator
Boston University
Collaborator
University of Massachusetts, Worcester
Collaborator
Washington University School of Medicine
Collaborator
University of Colorado, Denver
Collaborator
Columbia University
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
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 ...
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-2015-2020Sudden 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.
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-researchNew 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 ...
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-2022Sleep-Related Infant Deaths: Updated 2022 ...
The American Academy of Pediatrics recommends a safe sleep environment to reduce the risk of all sleep-related deaths.
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-deathSleep 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 ...
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