Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS) (SIDS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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
Sudden Infant Death Syndrome	Other: Lifestyle Counseling	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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: African American; Qualitative; Quantitative; SIDS; Infants

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, District of Columbia
Children's National Medical Center
Washington, D.C., District of Columbia, United States, 20010

Sponsors and Collaborators

Rachel Moon, MD

National Center for Research Resources (NCRR)

March of Dimes

Investigators

Principal Investigator:	Rachel Y Moon, MD	University of Virginia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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