Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS) (SIDS)
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ClinicalTrials.gov Identifier: NCT01361893 |
Recruitment Status
:
Completed
First Posted
: May 27, 2011
Last Update Posted
: July 2, 2017
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The overall purpose of this investigation is to better understand factors contributing to the high incidence of prone sleep positioning in African-American infants. In addition, the investigators are interested in investigating other races and ethinicities to understand their beliefs and perceptions and determine differences socioeconomically and socioculturally within and between groups. The investigators will address the following specific aims:
(-) To compare knowledge, attitudes, and practices regarding infant sleep position in parents of higher and lower SES.
(-) To identify risk factors for non-use of recommended supine sleep position in families with higher and lower SES (-) to develop a phenomenologic understanding of the decisions made by parents of higher SES and lower SES who do nt use recommended supine sleep position, using qualitative techniques.
Condition or disease | Intervention/treatment | Phase |
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Sudden Infant Death Syndrome | Other: Lifestyle Counseling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 616 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS) |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |
Arm | Intervention/treatment |
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Lifestyle Counseling
Parents who qualify for the study will be asked to participate in the survey portion of the study. informed consent will be obtained. After completing the survey each parent will be asked if they would be willing to participate in and additional interview (focus group or semi-structured in-debth interview) at a later date.
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Other: Lifestyle Counseling
We will utilize a combination of quantitative and qualitative techniques to ascertain factors, attitudes, and beliefs of African American parents of infants less than 6 months old.
Other Names:
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- Factors Influencing the Racial Disparity in SIDS [ Time Frame: December 2004 - June 2011 ]Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Parents who are 18 years old wth children less than 6 months old are eligible to participate if they self-identify as African American, with parents born in the United States.
Exclusion Criteria:
- If the parent is male, not the custodial parent of the child, unable to complet the interview in English or if their child has a chronis illness that would preclude use of the supine sleep position, severe gastroesophageal reflux or recent spinal surgery.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361893
United States, District of Columbia | |
Children's National Medical Center | |
Washington, D.C., District of Columbia, United States, 20010 |
Principal Investigator: | Rachel Y Moon, MD | University of Virginia |
Responsible Party: | Rachel Moon, MD, Clinical Research Administrator, University of Virginia |
ClinicalTrials.gov Identifier: | NCT01361893 History of Changes |
Other Study ID Numbers: |
3488 K24RR023681 ( U.S. NIH Grant/Contract ) |
First Posted: | May 27, 2011 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | June 2017 |
Keywords provided by Rachel Moon, MD, University of Virginia:
SIDS African American Infants Disparity |
Additional relevant MeSH terms:
Syndrome Death Infant Death Sudden Infant Death |
Disease Pathologic Processes Death, Sudden |