Improving counseling about safe sleep for infants using electronic records
Official title: Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths, (SAFE Start 2.0 Project)
Run by Johns Hopkins University · NCT05503771 · Data updated 2026-11-12
This study is testing a new tool to help pediatricians talk to parents about safe sleep for their babies during check-ups to reduce the risk of Sudden Infant Death Syndrome (SIDS).
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Days to 75 Years |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | September 30, 2022 |
| Main results expected | July 15, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT05503771 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English and Spanish-speaking parents or legal guardians bringing their infants for early well-baby visits at the Harriet Lane Clinic.
✕Probably not a fit
Patients with medically complex infants or those whose assigned resident is not participating in the study may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of an Infant Sleep Assessment (ISA) tool combined with motivational interviewing (MI) training for pediatricians during well-baby visits. The goal is to enhance communication between clinicians and parents regarding safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS) and related conditions. The ISA tool assesses parents' reported sleep practices and provides tailored feedback to clinicians through the electronic medical record. The study focuses on a pediatric clinic serving a socioeconomically disadvantaged population, primarily Black/African American families.
Why it matters
Potential benefit: If successful, this approach could lead to safer infant sleep practices and a reduction in the incidence of Sudden Unexplained Infant Death.
How similar studies have gone: Previous studies have shown success in using health information technology and communication training to improve patient outcomes, making this approach promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * English and Spanish-speaking parents and legal guardians bringing their infants to the Harriet Lane Clinic (pediatric primary care clinic) for any of their early well baby visits (between 3-5 days up to 4 weeks of age) * Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate. Exclusion Criteria: * Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.) * Assigned resident is not enrolled in the study
Where it's running
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Harriet Lane Clinic
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Barry Solomon, MD, MPH — Division of General Pediatrics
- Study coordinator: Marisa Cordon Villa de Leon, MPH
- Email: mcordon4@jh.edu
- Phone: 443-564-0185
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.