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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: Completed NA study, sponsored by Avera McKennan Hospital & University Health Center.
NCT03494621 is a NA study that has completed, run by Avera McKennan Hospital & University Health Center. The registered enrollment target is 115 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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?"
Primary Outcome
Primary outcome will be measured by participant report about infant sleep location and sleep position. Infant location is considered safe if participant reports a 'no' response to if the participant shared a sleep location with baby. INfant sleep position is considered safe if the participant provides a 'yes' response to whether the baby was put on its back to sleep for every sleep. The two responses will be aggregated together to derive that the participant is practicing safe sleep habits.If ei
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 |
What the finished NCT03494621 record still lists
NCT03494621 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Protecting Babies While they Sleep Curriculum is the first listed.
NCT03494621 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03494621's enrollment target sits among peer trials
115 810th of 2000 higher than 1,190 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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