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

Trial Summary

What is the purpose of this trial?

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents.

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 data supports the effectiveness of the treatment 'Online Support for Safe Infant Care Practices'?

Research shows that educating parents about safe sleep practices and breastfeeding can significantly reduce the risk of sudden infant death syndrome (SIDS). For example, a study found that safe sleep practices improved from 32% to 75% after implementing educational interventions in a nursery, highlighting the potential impact of such treatments. ^{1 2 3 4 5}

Is it safe to follow safe infant sleep practices?

Yes, following safe infant sleep practices is considered safe and is recommended to reduce the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths. These practices include placing infants on their backs to sleep in a safe environment, which has been shown to improve safety in newborn nurseries and neonatal intensive care units. ^{1 6 7 8 9}

How does the treatment 'Online Support for Safe Infant Care Practices' differ from other treatments for safe infant care?

This treatment is unique because it combines online support with education on breastfeeding, early brain development, and safe sleep practices, aiming to improve parent-child relationships and reduce risks like SIDS (Sudden Infant Death Syndrome). Unlike traditional methods, it uses an online platform to provide continuous support and education, making it more accessible and adaptable to individual family needs. ^{2 10 11 12 13}

Research Team

Rachel Y Moon, MD

Principal Investigator

University of Virginia School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Modeling of infant safe sleep practice in a newborn nursery: a quality improvement initiative. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sudden Unexpected Infant Death: Keeping the Newborn Safe in Hospital and at Home. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

TodaysBaby Quality Improvement: Safe Sleep Teaching and Role Modeling in 8 US Maternity Units. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

An Integrated Analysis of Maternal-Infant Sleep, Breastfeeding, and Sudden Infant Death Syndrome Research Supporting a Balanced Discourse. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Implementing safe sleep practices in a neonatal intensive care unit. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Safe Infant Sleep Interventions: What is the Evidence for Successful Behavior Change? [2019]

9. United States 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. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

An Update on Safe Infant Sleep. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Infant Care Practices, Caregiver Awareness of Safe Sleep Advice and Barriers to Implementation: A Scoping Review. [2022]

12. United States 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. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

An Interprofessional, Multimodal, Family-Centered Quality Improvement Project for Sleep Safety of Hospitalized Infants. [2021]