Online Support for Safe Infant Care Practices

(SUPERSONIC Trial)

Overseen By Katherine Boguszewski, MA

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Mental health issues, Minor, others

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

Compensation: Varies

Number of Visits: Unknown

3000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help new parents follow safe sleep and breastfeeding guidelines through private Facebook groups. Participants will receive educational videos and support from other parents to enhance these practices and reduce disparities between Black and White families. The trial includes groups focusing on safe sleep, breastfeeding (nursing or lactation), and early brain development. Pregnant individuals who are less than 30 weeks along and are enrolled in WIC, have Medicaid, or lack health insurance may be a good fit, especially if they have regular access to Facebook. As an unphased trial, this study provides new parents with a unique opportunity to gain valuable support and education in a community setting.

Will I have to stop taking my current medications?

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

What prior data suggests that these online support practices are safe for infant care?

Research has shown that using Facebook groups for breastfeeding support is generally safe and well-liked. Many mothers find these groups helpful because they offer support that might be hard to find elsewhere. Studies indicate that mothers in these groups often feel part of a community where breastfeeding is understood and encouraged.

For safe sleep practices, studies have examined photos and discussions shared online. These studies suggest that social networks can positively influence how mothers practice safe sleep for their babies, helping to reduce risks like sudden infant death syndrome (SIDS).

Combining these two areas—safe sleep and breastfeeding support within online groups—has been considered safe and beneficial. The American Academy of Pediatrics supports safe sleep education to lower the risk of sleep-related infant deaths. Online communities can effectively spread this important information.

Overall, using Facebook groups to share information on breastfeeding and safe sleep is safe and can be a valuable resource for parents seeking guidance and community support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support new parents in adopting safe infant care practices through online communities. Unlike traditional methods that might involve in-person classes or pamphlet distribution, this approach uses private Facebook groups to deliver evidence-based education on breastfeeding, safe sleep, and early brain development. These groups not only provide multimedia learning resources but also foster social connections among parents, which can enhance mutual support and motivation. This trial aims to determine if this online, community-focused model can more effectively promote healthy practices compared to conventional educational methods.

What evidence suggests that this trial's treatments could be effective?

Research shows that online support can significantly aid in safe sleep and breastfeeding practices. In this trial, participants will join different Facebook groups focusing on specific areas. For those in the Safe Sleep arm, studies have found that social networks greatly influence how new mothers put their babies to sleep. Being part of a supportive online community could help mothers follow safe sleep guidelines, such as placing babies on their backs to sleep. Participants in the Breastfeeding arm will receive support through Facebook groups, which evidence shows can help mothers breastfeed for longer. Specifically, one study found that this support can help mothers exclusively breastfeed for six months. These findings suggest that online communities might effectively improve both safe sleep and breastfeeding practices. ^{1 3 6 7 8}

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 pregnant individuals in the U.S. who are less than 30 weeks along, enrolled or enrolling at a WIC center, speak English, and have daily access to Facebook and SMS texting.

Inclusion Criteria

Must live in the United States

Must be English speaking

I am pregnant and less than 30 weeks along.

Exclusion Criteria

Not planning to live in the same home as infant after birth

Prenatal diagnosis expected to impact on infant care practices in a manner not compatible with study goals, including contraindications to breastfeeding or supine infant sleep positioning

Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants join a private Facebook group from approximately 32 weeks gestation to 6 months postpartum, receiving evidence-based education and social support.

Approximately 8 months

Online engagement

Follow-up

Participants are monitored for adherence to safe sleep and breastfeeding practices through surveys.

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Breastfeeding
• Early Brain Development and Parent-Child Relationships
• Safe Sleep

Trial Overview

The study tests if private Facebook groups providing multimedia education on safe sleep practices and breastfeeding can improve adherence to these practices and reduce racial disparities.

How Is the Trial Designed?

Group I: Safe Sleep and Breastfeeding Experimental Treatment 2 Interventions

Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and breastfeeding, and b) an online community and social network of other pregnant WIC clients and new parents

Group II: Safe Sleep Experimental Treatment 1 Intervention

Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and b) an online community and social network of other pregnant WIC clients and new parents

Group III: Breastfeeding Experimental Treatment 1 Intervention

Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents

Group IV: Early Brain Development and Parent -Child Relationships Active Control 1 Intervention

Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for early brain development and parent-child interactions (control intervention) and b) an online community and social network of other pregnant WIC clients and new parents.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A quality improvement initiative using visual cues and nursing education significantly increased safe sleep practices in a low-volume nursery, improving compliance from 32% to 75%.

This study highlights the effectiveness of targeted interventions in promoting safe sleep environments for infants, which is crucial in reducing the risk of sudden infant death syndrome (SIDS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling of infant safe sleep practice in a newborn nursery: a quality improvement initiative. Hsu, E., Isbell, L., Arnold, D., et al.[2023]

A quality improvement intervention across eight US hospital maternity units significantly increased mothers' knowledge of safe sleep practices, with reported education rates rising from baseline to between 72% and 95%.

The intervention also resulted in 93% of infants being observed sleeping on their backs and 88% in safe sleep environments, with these improvements sustained for up to 12 months post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TodaysBaby Quality Improvement: Safe Sleep Teaching and Role Modeling in 8 US Maternity Units. Kellams, A., Parker, MG., Geller, NL., et al.[2018]

Nurses play a crucial role in educating parents about Sudden Infant Death Syndrome (SIDS) risk reduction, as highlighted by the American Academy of Pediatrics' policy statement.

Despite a decline in SIDS rates, it remains the leading cause of postneonatal infant mortality, indicating a need for improved and consistent dissemination of risk reduction guidelines by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating parents about the risk factors of sudden infant death syndrome: the role of neonatal intensive care unit and well baby nursery nurses. Esposito, L., Hegyi, T., Ostfeld, BM.[2007]

The updated guidelines from the American Academy of Pediatrics emphasize the importance of safe infant sleep practices, including breastfeeding, skin-to-skin contact, and the risks associated with bed-sharing and loose bedding.

Nurses and clinicians are encouraged to model safe sleep behaviors and engage in discussions with parents about these practices during hospital stays to promote infant safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Update on Safe Infant Sleep. Hitchcock, SC.[2019]

Educating parents about safe sleep practices and breastfeeding is crucial in reducing the risk of sudden unexpected infant death, but current methods have not achieved widespread adherence.

Prenatal counseling using a conversational and motivational approach can effectively address barriers and help parents adopt safe sleep and breastfeeding practices in a sustainable way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden Unexpected Infant Death: Keeping the Newborn Safe in Hospital and at Home. Kellams, A., Feldman-Winter, L.[2021]

Research indicates that breastfeeding at night can enhance the benefits of exclusive breastfeeding, yet concerns about infant deaths have led to controversial views on co-sleeping practices.

Policies should focus on safe sleep practices that allow for bed-sharing under non-hazardous conditions, while further research is needed to clarify the circumstances surrounding infant deaths and improve public health guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Analysis of Maternal-Infant Sleep, Breastfeeding, and Sudden Infant Death Syndrome Research Supporting a Balanced Discourse. Marinelli, KA., Ball, HL., McKenna, JJ., et al.[2021]

Sudden infant death syndrome (SIDS) and other sleep-related deaths account for over 4,000 infant deaths annually in the USA, highlighting the urgent need for effective interventions.

The review discusses various safe sleep interventions that have been implemented to change infant sleep practices, noting that while some caregivers resist these evidence-based recommendations, there is evidence supporting their effectiveness in reducing sleep-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Infant Sleep Interventions: What is the Evidence for Successful Behavior Change? Moon, RY., Hauck, FR., Colson, ER.[2019]

A project in a neonatal intensive care unit (NICU) revised its safe sleep policy based on updated American Academy of Pediatrics (AAP) recommendations, leading to a significant increase in safe sleep compliance from 21% to 88% among eligible infants.

The implementation of staff education, family resources, and wearable blankets contributed to improved patient safety by promoting safer sleep environments for infants, effectively reducing the risk of Sudden Infant Death Syndrome (SIDS) and accidental suffocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing safe sleep practices in a neonatal intensive care unit. Voos, KC., Terreros, A., Larimore, P., et al.[2022]

A scoping review of 137 articles highlights the importance of modifiable infant sleep practices in reducing the risk of sleep-related infant mortality, emphasizing the need for effective public health messaging.

The review indicates that while caregivers are aware of safe sleep advice, there are significant challenges in implementing these recommendations, suggesting a need for ongoing monitoring and targeted support for at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Care Practices, Caregiver Awareness of Safe Sleep Advice and Barriers to Implementation: A Scoping Review. Cole, R., Young, J., Kearney, L., et al.[2022]

The American Academy of Pediatrics updated their safe sleep guidelines for infants, emphasizing the importance of healthcare providers modeling safe sleep behaviors, which is crucial for effective communication with families during hospital stays.

A quality improvement project implemented five family-centered interventions, including a safe sleep web page and bedside guides, which successfully enhanced sleep safety for hospitalized infants by fostering collaboration among healthcare providers and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Interprofessional, Multimodal, Family-Centered Quality Improvement Project for Sleep Safety of Hospitalized Infants. Erlick, M., Fioravanti, ID., Yaeger, J., et al.[2021]

The study of 253 families in the UK found a strong link between breastfeeding and bed-sharing, suggesting that parents who breastfeed are more likely to share a bed with their infants during the night.

Bed-sharing may support breastfeeding practices, highlighting the importance of discussing safe bed-sharing strategies with parents to promote breastfeeding and enhance infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding, bed-sharing, and infant sleep. Ball, HL.[2019]

Despite existing guidelines from the American Academy of Pediatrics, SIDS and SUID remain significant causes of infant mortality in the U.S., indicating a need for improved education on safe sleep practices.

Nurses often lack the necessary training and knowledge to model safe sleep practices, highlighting the importance of expanding educational efforts for both healthcare providers and parents to reduce the risks associated with SIDS and SUID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a Safe Sleep Environment for the Infant: What the Pediatric Nurse Needs to Know. Newberry, JA.[2019]

An online educational module significantly improved mothers' knowledge about SIDS risk-reduction recommendations for preterm infants, with knowledge ratings increasing after viewing the module and remaining elevated four weeks post-discharge.

Despite the increase in knowledge, some SIDS prevention practices were not fully adopted, as only 71% of infants slept in the parents' room and only 41% received breast milk, indicating a need for ongoing support and education for parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring about Preemies' Safe Sleep (CaPSS): An Educational Program to Improve Adherence to Safe Sleep Recommendations by Mothers of Preterm Infants. Dowling, DA., Barsman, SG., Forsythe, P., et al.[2019]

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