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OpenTrials
Completed

NCT Number: NCT01361893

Factors Influencing the Racial Disparity in Sudden Infant Death Syndrome (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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle counseling

Other

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

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • March of Dimes
  • National Center for Research Resources (NCRR)

Registry information

Acronym: SIDS

Important dates

Study start
2004
Primary completion
2015
Study completion
2015
First posted
May 27, 2011
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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