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Trial record 1 of 16 for:
"Sudden infant death syndrome"
Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS) (SIDS)
This study has been completed.
Sponsor:
Rachel Moon
Collaborators:
National Center for Research Resources (NCRR)
March of Dimes
Information provided by (Responsible Party):
Rachel Moon, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01361893
First received: May 12, 2011
Last updated: October 16, 2015
Last verified: October 2015
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Purpose
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 | Intervention |
|---|---|
| Sudden Infant Death Syndrome | Other: Lifestyle Counseling |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS) |
Resource links provided by NLM:
Further study details as provided by Rachel Moon, Children's Research Institute:
Primary Outcome Measures:
- 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)
| Enrollment: | 616 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2015 |
| Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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:
|
Detailed Description:
Epidemiologic studies have demonstrated prone position to be a major risk factor for SIDS. Studies have consistently demonstrated an increased rate of prone positioning in African American infants, but very little is known about the reasons why African American parents use the prone position more often than other racial groups. Furthermore, no studies have taken advantage of the observed socioeconomic status associated variablility in SIDS and prone sleeping within the African American community. By examing within-group differences, it is possible to move beyond comparative racial descriptions (i.e. comparisions of white and African American) to identification of potentially modifiable factors that might respond to culturally acceptable interventions within a disadvantaged group.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361893
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361893
Locations
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
Sponsors and Collaborators
Rachel Moon
National Center for Research Resources (NCRR)
March of Dimes
Investigators
| Principal Investigator: | Rachel Y Moon, MD | Children's Research Institute |
More Information
| Responsible Party: | Rachel Moon, Clinical Research Administrator, Children's Research Institute |
| ClinicalTrials.gov Identifier: | NCT01361893 History of Changes |
| Other Study ID Numbers: |
3488 K24RR023681 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | May 12, 2011 |
| Last Updated: | October 16, 2015 |
Keywords provided by Rachel Moon, Children's Research Institute:
|
SIDS African American Infants Disparity |
Additional relevant MeSH terms:
|
Syndrome Death Sudden Infant Death Infant Death |
Disease Pathologic Processes Death, Sudden |
ClinicalTrials.gov processed this record on June 22, 2017