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

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.

Study Overview

• Status: Completed
• Conditions: Sudden Infant Death Syndrome
• Intervention / Treatment: Other: Lifestyle Counseling

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 Type: Interventional
• Enrollment (Actual): 616
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors Influencing the Racial Disparity in SIDS	Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)	December 2004 - June 2011

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Center for Research Resources (NCRR); March of Dimes
• Investigators: Principal Investigator: Rachel Y Moon, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: African American; Infants; SIDS; Disparity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Death, Sudden; Syndrome; Death; Infant Death; Sudden Infant Death
• Other Study ID Numbers: 3488; K24RR023681 (U.S. NIH Grant/Contract)