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

Sudden Infant Death Syndrome Clinical Trial

— SIDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361893
• Other study ID #: 3488
• Secondary ID: K24RR023681
• Status: Completed
• Phase: N/A
• Start date: December 2004
• Est. completion date: September 2015

Study information

• Verified date: October 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 616
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Infant Death
• Sudden Infant Death
• Sudden Infant Death Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	March of Dimes, National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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