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

Sponsor

University of Virginia (Other)

Overall Status

Completed

CT.gov ID

NCT01361893

Collaborator

National Center for Research Resources (NCRR) (NIH), March of Dimes (Other)

616

Enrollment

Location

Arm

129

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sudden Infant Death Syndrome	Other: Lifestyle Counseling	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

616 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Factors Influencing the Racial Disparity in SIDS [December 2004 - June 2011]
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.