Clinical trial Recruiting at 1 site Interventional Ages Any age to 3 Months

Safe Sleep Habits for Infants in the Pediatric Emergency Department

Official title: A Pediatric Emergency Department-based Intervention to Increase Infant Adherence to Safe Sleep Practices

Run by State University of New York at Buffalo · NCT07779512 · Data updated 2026-11-12

This study tests whether adding a daily safe sleep tracking tool to brief education helps families follow safe sleep guidelines for infants 0–4 months more consistently than education alone.

Quick facts

Study typeInterventional
AgesAny age to 3 Months
SexAll
Enrollment214 (estimated)
SponsorState University of New York at Buffalo
Academic / other
Locations1 site (Buffalo, New York)
StatusRecruiting
StartedAugust 17, 2026
Main results expectedAugust 1, 2027
Study endsSeptember 1, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07779512 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Infants aged 0 to under 4 months and their English-speaking, primary caregivers who are not fully adherent to all four safe sleep guidelines at the ED.

Probably not a fit

Caregivers who fully adhere to safe sleep guidelines at presentation or those unlikely to engage with follow-up surveys may derive no additional benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Infant safe sleep reduces the risk of SIDS and related deaths when caregivers follow recommended practices. In this interventional study, families receive brief safe sleep education plus a daily tracking tool, with the goal of improving adherence to four key safe sleep behaviors compared with education alone. Eligible participants are English-speaking legal guardians of hospitalized or evaluated infants under 4 months who are not fully adherent to all four guidelines at the ED visit. The study uses habit tracking alongside education to encourage sustained behavior change and periodic follow-up surveys to assess adherence over time. Conducted at Golisano Children’s Hospital of Buffalo, led by SUNY Buffalo, the trial integrates caregiver support with practical tools to reinforce safe sleep practices.

Why it matters

Potential benefit: If successful, caregivers may maintain higher adherence to safe sleep practices, potentially reducing sleep-related infant risks.

How similar studies have gone: Previous pediatric ED education interventions improved some safe sleep behaviors, but gains were variable and not always sustained; this study tests if daily tracking adds lasting benefit.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Legal guardian of infants ages 0 to \< 4 months , evaluated in GCHB PED ages 0 to \< 4 months
* English speaking primary caregiver of infant
* Infant ED triaged ESI 2-5
* Able to complete follow-up surveys via phone or email
* Family not completely adherent to all 4 pre-determined safe sleep guideline recommended behaviors. If they are adherent to 3 out of 4 guidelines, they are eligible for the study.

Exclusion Criteria:

* Infants requiring intensive interventions where PED education is not feasible
* Non-English-speaking primary caregiver
* Legal guardian unable to complete baseline survey or provide follow-up contact
* Legal guardian completely adherent to safe sleep guidelines

Where it's running

  • Golisano Children's Hospital of Buffalo
    Buffalo, New York, United States
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.