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NCT03494621 · ClinicalTrials.gov registry record · NA
Infant Care Practices Study
A NA study, sponsored by Avera McKennan Hospital & University Health Center.
- Completed
- Registry status
- NA
- Development phase
- 115
- Enrollment target
NCT03494621 is a NA study that has completed, run by Avera McKennan Hospital & University Health Center. The registered enrollment target is 115 participants.
The verdict
NCT03494621, a NA study, has completed, sponsored by Avera McKennan Hospital & University Health Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
Study Summary
This proposed project will engage American Indian communities through existing partnerships, utilizing a Community Based Participatory Research (CBPR) methodology to design a group intervention program to increase the safety of infant sleep environments. Compelling evidence from research in other racial populations suggests that family and cultural norms, attitudes and personal beliefs about infant sleep, safety and comfort are strongly associated with the choice of infant sleep environment. It may be possible that the current safe sleep messages are in conflict with inherent cultural beliefs within these communities. This conflict with the scientific recommendations regarding safe sleep may influence behavior, even in the presence of adequate knowledge about safe sleep practices. Preliminary discussions with many tribal leaders and elders suggest that this chasm between culture and scientific recommendations can be bridged with an intervention incorporating culture, education and resources. However, there is limited research on factors influencing infant safe sleep practices of American Indian mothers. This study will test the effectiveness of incorporating cultural beliefs and practices into an intervention package based on the American Academy of Pediatrics safe sleep guidelines that incorporates both education and provision of resources. Therefore, the research question is: "Does a culturally specific safe sleep intervention, developed using CBPR, reduce the risk of unsafe infant sleep practices in Northern Plains American Indian communities?"
Interventions
- BEHAVIORAL Protecting Babies While they Sleep Curriculum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2018-03-28 |
| Est. Completion | 2022-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03494621
The ClinicalTrials.gov registry entry for NCT03494621 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 115 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avera McKennan Hospital & University Health Center, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Protecting Babies While they Sleep Curriculum is the first listed.
NCT03494621 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03494621 about?
NCT03494621 is a clinical study titled "Infant Care Practices Study". This proposed project will engage American Indian communities through existing partnerships, utilizing a Community Based Participatory Research (CBPR) methodology to design a group intervention program to increase the safety of infant sleep environments. Compelling evidence from research in other ra...
What is the current status of trial NCT03494621?
This trial is currently completed. It is a NA study. The enrollment target is 115 participants. The study started on 2018-03-28. Estimated completion is 2022-05-30.
What interventions are being tested in trial NCT03494621?
The interventions under investigation include: Protecting Babies While they Sleep Curriculum (BEHAVIORAL).
Who is sponsoring clinical trial NCT03494621?
This trial is sponsored by Avera McKennan Hospital & University Health Center, which has 20 total clinical trials registered on ClinicalTrials.gov.
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