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NCT06618586 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2025-06-11

No results posted yet for this study

Summary

This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.

Conditions

  • Infant Death
  • Sudden Infant Death

Interventions

BEHAVIORAL

TodaysBaby

The TodaysBaby intervention is comprised of: 1) Text message-delivered, short educational videos in the first 2 months after birth, with each video timed to match content addressing anticipated barriers and facilitators to adhering to guidelines (e.g. parental concerns that infant will choke while supine). Participants will also have access to a web portal where intervention videos will be maintained. 2) Text queries regarding safe sleep practices, which collect data on sleep practices in near real-time and provide reinforcement of adherence. Mothers will receive 1-2 text message questions weekly that assess sleep practices in near real-time .

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER
  • Boston Medical Center

    collaborator OTHER
  • Boston University

    collaborator OTHER
  • University of Massachusetts, Worcester

    collaborator OTHER
  • Columbia University

    collaborator OTHER
  • University of Colorado, Denver

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • University of Virginia

    lead OTHER

Principal Investigators

  • Rachel Y Moon, MD · University of Virginia School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-06-01
Completion
2028-06-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618586 on ClinicalTrials.gov