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

This study has been completed.
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Children's Research Institute:

Primary Outcome Measures:
  • Factors Influencing the Racial Disparity in SIDS [ Time Frame: December 2004 - June 2011 ] [ Designated as safety issue: Yes ]
    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:
  • African American
  • Qualitative
  • Quantitative
  • SIDS
  • Infants

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)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 
Study First Received: May 12, 2011
Last Updated: October 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
SIDS
African American
Infants
Disparity

Additional relevant MeSH terms:
Syndrome
Death
Infant Death
Sudden Infant Death
 Disease
Pathologic Processes
Death, Sudden

ClinicalTrials.gov processed this record on September 23, 2016