Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS) (SIDS)
Primary Purpose
Sudden Infant Death Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Sudden Infant Death Syndrome focused on measuring SIDS, African American, Infants, Disparity
Eligibility 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.
Sites / Locations
- Children's National Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lifestyle Counseling
Arm Description
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.
Outcomes
Primary Outcome Measures
Factors Influencing the Racial Disparity in SIDS
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)
Secondary Outcome Measures
Full Information
NCT ID
NCT01361893
First Posted
May 12, 2011
Last Updated
October 17, 2018
Sponsor
University of Virginia
Collaborators
National Center for Research Resources (NCRR), March of Dimes
1. Study Identification
Unique Protocol Identification Number
NCT01361893
Brief Title
Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)
Acronym
SIDS
Official Title
Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Center for Research Resources (NCRR), March of Dimes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Infant Death Syndrome
Keywords
SIDS, African American, Infants, Disparity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
616 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Counseling
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lifestyle Counseling
Other Intervention Name(s)
African American, Qualitative, Quantitative, SIDS, Infants
Intervention Description
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.
Primary Outcome Measure Information:
Title
Factors Influencing the Racial Disparity in SIDS
Description
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)
Time Frame
December 2004 - June 2011
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Y Moon, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (SIDS)
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