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

NCT01361893 | Completed DMC

• 2 other identifiers: 3488K24RR023681
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Infant Death Syndrome

Keywords

SIDS; African American; Infants; Disparity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lifestyle Counseling

OTHER

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

Interventions

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.

Also known as: African American, Qualitative, Quantitative, SIDS, Infants

Lifestyle Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• National Center for Research Resources (NCRR): collaborator
• March of Dimes: collaborator

Study Sites (1)

Children's National Medical Center

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

Location

MeSH Terms

Conditions

Sudden Infant Death

Interventions

Evaluation Studies as Topic

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Intervention Hierarchy (Ancestors)

Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Rachel Y Moon, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 27, 2011
• Study Start: December 1, 2004
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 19, 2018

Record last verified: 2018-10

Locations

US (1)