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Recruiting NCT05503771

NCT05503771 Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record

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Clinical Trial Summary
NCT ID NCT05503771
Status Recruiting
Phase
Sponsor Johns Hopkins University
Condition Sudden Infant Death
Study Type INTERVENTIONAL
Enrollment 350 participants
Start Date 2022-09-30
Primary Completion 2026-07-01

Trial Parameters

Condition Sudden Infant Death
Sponsor Johns Hopkins University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 350
Sex ALL
Min Age 3 Days
Max Age 75 Years
Start Date 2022-09-30
Completion 2026-07-01
Interventions
ISA-MIStandard of Care (SOC)

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Brief Summary

The study team will evaluate the impact of an Infant Sleep Assessment (ISA) tool with motivational interviewing (MI) communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent reported and observed infant sleep practices. The study team's hypotheses are that 1) clinicians who utilize the ISA with MI training will more effectively communicate safe sleep information to their patients' parents, and 2) these parents will have safer infant sleep practices than parents whose clinicians are in a standard of care control group.

Eligibility 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

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