An interventional study of Protecting Babies While they Sleep Curriculum in Sudden Infant Death, sponsored by Avera McKennan Hospital & University Health Center. Completed at 1 site in United States. Open to female participants aged 14 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by Avera McKennan Hospital & University Health Center · Not applicable, Interventional, and Prevention
Among 51 studies in Sudden Infant Death with a site in United States — 10 open to participants now, 15 under way, 4 of them phase 3. Sudden Infant Death · United States.
Among the 51 studies in Sudden Infant Death with a site in United States, this one is the 16th largest by enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2018, is one of 17 with no phase, and was the 29th registered.
80 studies on the registry are indexed under Sudden Infant Death; 14 are open to participants now.
Browse Sudden Infant Death studies →10 of the 51 studies in Sudden Infant Death with a site in United States are open now. Recruiting first, the newest first:
State University of New York at Buffalo · Sites in United States
University of Virginia · Sites in United States
Johns Hopkins University · Sites in United States
University of California, San Francisco · Sites in United States
Paul Szabolcs · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Sudden Infant Death studies recruiting now, 4 (44%) set no upper age limit and 5 (56%) stop at 75 or younger; 7 take children under 18; 2 take healthy volunteers.
This study: 14 Years to 49 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 14 · Phase 3 9 · Phase 4 1
First in 2003; this study’s year is marked. 4 started in 2018.
This study's enrollment of 115 is above the median of 60 across 51 interventional studies indexed under Sudden Infant Death.
Median enrollment 96 across the 37 interventional studies, 29 across the 14 observational. Of the 33 that completed or were terminated, 12 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 51 have an industry lead sponsor. The 10 most frequent:
Avera McKennan Hospital & University Health Center is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Avera McKennan Hospital & University Health Center has 1 study filed under Sudden Infant Death — fewer than ten, so there is no comparison to draw.
4 of the studies in Sudden Infant Death with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06075537Phase 3Denali Therapeutics Inc.An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007 | 2027-06 |
| NCT01962415Paul SzabolcsReduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT | 2026-11 |
| NCT06618586University of VirginiaGet Social Media and Risk-Reduction Training | 2027-06-01 |
| NCT07779512State University of New York at BuffaloInfant Safe Sleep in Pediatric Emergency Depratment | 2027-08-01 |
Among the 51 studies in Sudden Infant Death with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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?"
The proposed study is a two-group randomized trial with a total sample size of 150. Pregnant women from Western South Dakota who meet eligibility criteria will be randomly assigned to an intervention or a control group and will be followed through their pregnancy and postnatal period until their infant reaches one year of age. They will remain in their randomized group throughout the course of the study.
Intervention group: Participants randomly assigned to the intervention group will have three prenatal contacts at study site offices. These contacts will include collection of covariate data, engagement with the Protecting Babies While They Sleep curriculum and activities (described below) led by trained study staff, and assessment of the overall session quality and acceptability. Participants will be allowed to invite up to two family members or other support persons to attend the third prenatal contact. The research coordinator will review the consent form and request consent for each guest of the participant. Guests will be asked to provide a subset of the covariate data provided by the primary participant, engage with the curriculum and associated activities, and assess the overall session quality and acceptability.
The intervention curriculum derives from information gathered at previously conducted focus groups and interviews, which aimed to ascertain the role of caregiver knowledge, beliefs, and access to resources in implementation of infant safe sleep practices. The study investigators worked with a Community Advisory Board (CAB) to design the focus group and interview questions, interpret the resulting qualitative data, and guide development of the intervention curriculum. The curriculum combines culturally-based prenatal and infant care education with current safe sleep recommendations from the American Academy of Pediatrics (AAP). The main components include: brief videos featuring medical professionals and American Indian elders, discussion guided by Motivational Interviewing principles, and culturally-based activities designed to reinforce the curriculum objectives.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomly assigned to the control group will have three prenatal contacts at the same gestational ages as the intervention participants. These contacts will include collection of covariate data, review of locally available educational materials on pregnancy/infant care led by trained study staff, and assessment of the overall session quality and acceptability. The educational materials provided during these sessions are drawn from materials currently available at local health care facilities
The intervention curriculum derives from information gathered at previously conducted focus groups and interviews, which aimed to ascertain the role of caregiver knowledge, beliefs, and access to resources in implementation of infant safe sleep practices. The protocol for the focus groups and interviews has been reviewed by the Tribal Institutional Review Board. The focus groups were conducted in Rapid City and a western Tribal reservation with pregnant adult women and pregnant, parenting, or other interested adolescent women; fathers (adult men); and elder women. Two focus groups were held for each category of individuals. Additional qualitative data was collected via key informant interviews with individuals vested and experienced in maternal and child health.
Behavioral: Protecting Babies While they Sleep Curriculum
The intervention curriculum derives from information gathered at previously conducted focus groups and interviews, which aimed to ascertain the role of caregiver knowledge, beliefs, and access to resources in implementation of infant safe sleep practices. .
Implementation of safe sleeping practices
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 either question indicates unsafe sleeping habits, the participant will be counted as not practicing safe sleeping habits.
Time frame: Three months
Change in Safe Sleep knowledge
The impact of the intervention on the participant's knowledge of safe sleep will be assessed through participant self report.
Time frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year
Change in beliefs regarding infant safe sleep
The impact of the intervention on the participants' belief regarding infant safe sleep will be measured through self report
Time frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year
Change in safe sleep practice
The impact of the intervention on the participants' practice of safe sleep will be measured through self report
Time frame: prenatal, 3 months postnatal, 6 months postnatal, 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The investigators understand that sharing of research data with the broad research community promotes collaboration and further development of the scientific field. The investigators intend to share de-identified data with NIH in accordance with tribal policies and regulations. The investigators anticipate that a detailed plan will be in place to allow for sharing of data after analysis and publication of the primary hypothesis.
Ran from Mar 2018 to primary completion in Oct 2021, 43 months.
Of 15 interventional studies with no phase under Sudden Infant Death, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 43 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Avera McKennan Hospital & University Health Center