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Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial
Eileen M McDonald1,2, Amanda Davani1,3, Akisha Price1,3
1Johns Hopkins Center for Injury Research and Policy, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Insights
The Safe Start Study is evaluating a safe sleep intervention to improve infant sleep safety. This research aims to enhance parental knowledge and behaviors for safer infant sleep environments.
Area of Science:
- Pediatric primary care
- Public health interventions
- Child safety
Background:
- Limited randomized controlled trials (RCTs) exist for infant sleep practices.
- Integrating safe sleep information into routine pediatric anticipatory guidance is under-researched.
- The Safe Start Study protocol addresses this gap by evaluating a safe sleep intervention.
Purpose of the Study:
- To assess the impact of safe sleep interventions on parental knowledge, beliefs, and behaviors.
- To promote the creation and maintenance of safe infant sleep environments.
- To advance evidence-based interventions in primary care settings for high-risk families.
Main Methods:
- A three-group randomized controlled trial (RCT) comparing a safe sleep intervention, an attention-matched control (scald burn prevention), and standard care.
- Data collection includes baseline surveys at 2-week well-child visits (WCVs), and follow-up surveys and home observations at 2-4 weeks and 2-3 months.
- Participants are mother-baby dyads and their pediatricians in a large urban primary care practice.
Main Results:
- Primary outcomes include self-reported infant sleep behaviors (alone, on back, in crib, smoke-free), observed sleep environments, pediatrician counseling, and exposure to a city-wide safe sleep campaign.
- The study aims to provide data on the effectiveness of integrating safe sleep education into WCVs.
- Results will inform future clinical practice and public health strategies for infant safe sleep.
Conclusions:
- A theory-driven, evidence-based safe sleep intervention is a priority for research and clinical practice.
- This study will contribute to improving infant sleep safety through educational and environmental interventions.
- Findings are expected to enhance the application of safe sleep practices in primary care settings.
Background:
Few randomised controlled trials (RCTs) have been conducted to improve infant sleep practices. There is limited research on how best to integrate safe sleep information into routine paediatric anticipatory guidance delivered at well child visits (WCVs). This protocol paper describes the design of the Safe Start Study, which aims to evaluate the impact of safe sleep interventions on parents' knowledge, beliefs and behaviours related to creating and maintaining a safe sleep environment for their infants.
Methods:
Safe Start is a three-group RCT comparing a safe sleep health education intervention delivered as part of the 2-week WCV, an attention-matched control group that receives a scald burn prevention intervention, and a standard of care group. A baseline survey is completed at the 2-week WCV; follow-up surveys and observations are completed in the home at 2-4 weeks and 2-3 months. Participants include mother-baby dyads attending a large urban paediatric primary care practice and their paediatricians. Primary outcomes are self-reported behaviours (baby sleeps alone, on back, in crib and in a smoke-free environment), observations of the sleep environment, paediatricians' anticipatory guidance counselling about safe sleep and participants' reported exposure to an existing city-wide safe sleep campaign.
Discussion:
Providing a theory-driven and evidenced-based safe sleep intervention is both a research and a clinical practice priority. This study will advance the application of educational and environmental interventions in the primary care setting to improve the safety of infant sleep environments in high-risk families.
Trial Registration Number:
NCT03070639; Pre-results.
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