We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Reduce African-American Infant Mortality (SIDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01361880
Recruitment Status : Completed
First Posted : May 27, 2011
Last Update Posted : July 5, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The overall purpose of this randomized trial is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment. African-American parents of newborn, healthy term infants will be randomized to receive either a standard message to avoid bedsharing, eliminate use of soft bedding and soft sleep surfaces, and to place infants in the supine position for sleep to reduce the risk of SIDS or an enhanced message to avoid these behaviors to both reduce the risk of SIDS and to prevent infant suffocation.

Condition or disease Intervention/treatment
Health Behavior Behavioral: Reduce Infant Mortality

Detailed Description:

A persistent, significant racial disparity exists in infant mortality rates attributable to Sudden Infant Death Syndrome (SIDS) and other types of sleep-related sudden unexpected infant death (SUID), such as suffocation and undetermined causes of death. SIDS and other sleep-related deaths account for ~4600 U.S. deaths annually.4 While the incidence of SIDS has declined, infant deaths from accidental suffocation and strangulation in bed have quadrupled.5 Additionally, racial disparities in SIDS and other sleep-related deaths have increased over the past decade, with African-American infants twice as likely to die as other infants.6, 7 Certain infant sleeping practices, such as prone (stomach) sleeping, use of soft bedding and soft sleep surfaces, and bedsharing, likely play a significant role, both in SIDS and SUID, and in the disparities seen therein. Elimination of health barriers and racial/ethnic disparities, and promoting healthy development, have been highlighted as MCHB research priorities; this application is directly responsive to both of these priorities.

In the current system, health care providers and public health messages, using the American Academy of Pediatrics (AAP) recommendations,8 stress the use of supine (back) positioning, avoidance of soft bedding, and room sharing without bedsharing as recommendations to reduce the risk of SIDS. However, our research suggests that African-Americans have problems with this message, as they have a low degree of self-efficacy with regards to SIDS risk reduction (i.e., they do not believe that their actions can make a difference in whether SIDS occurs) and are suspicious of the concept of "risk reduction."2 However, African-American parents have a high degree of self-efficacy with regards to preventing infant suffocation. Given the increasing number of suffocation and other preventable sleep-related deaths and the fact that many of the behavioral risk factors for both SIDS and preventable sleep-related deaths are the same, providing parents with an additional safe sleep message that emphasizes prevention of suffocation may be more effective in changing parent behavior. Such a message would be carefully crafted based on our current community-based research1-3 to address emerging risks of greatest concern and potential self-efficacy. A simple, easily reproducible change in the system of newborn care could thus address a critical barrier to further progress in reducing infant mortality rates, particularly among African American families. The best systems of care to reduce disparities must use the best available and culturally competent messaging based on strong empirical evidence and require rigorous evaluation.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomized Messaging Trial to Reduce African-American Infant Mortality
Study Start Date : June 2011
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Reduce infant mortality
The overall purpose of this study is to develop and evaluate a systematic approach to improve African-American parental behaviors specifically with regards to the infant sleep environment
Behavioral: Reduce Infant Mortality
The study's long term goal is to disseminate a new easily implemented and reproducible intervention that based on our previous research is culturally competent and provides a rationale for changing infant sleep position and sleep environment. This intervention if successful will quickly be disseminated and will be an important change to the system of newborn care; the resultant change in parental behavior would ultimately result in a reduction in sleep-related infant mortality rates thereby promoting healthy development.After written consent has been obtained, a brief survey about knowledge of and attitudes toward safe sleep position recommendations, current intent with regards to safe sleep recommendations, and demographics will be completed. Contact information will be obtained from participants to facilitate study follow-up at two weeks of infants birth 2-3 months and 5-6 months.
Other Names:
  • African Americans
  • Anticipatory guidance
  • Health Promotion
  • Infant Mortality
  • Injury Prevention
  • Nurses
  • Parent Education
  • Sudden Infant Death Syndrome

Outcome Measures

Primary Outcome Measures :
  1. Suffocation, Strangulation and Sudden Infant Death Syndrome [ Time Frame: Three years ]
    Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The purpose of the study is to determine the impact of a new educational strategy on African American parents, all participants will be self identified as African American. Although male parents will be allowed to participate in the followup surveys, female parents will be the primary focus of this study.

Exclusion Criteria:

  • Mothers under the age of 18 years will not be included in the study. Infants born with congenital anomalies that would prevent them from sleeping in the supine position or if the infant is born at less than 36 weeks gestation, requires hospitalization for more than 1 week, or has ongoing medical problems.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361880

United States, District of Columbia
Washington Hospital Center
Washington, D.C., District of Columbia, United States, 20010
Sponsors and Collaborators
University of Virginia
Children's Research Institute
Washington Hospital Center
Principal Investigator: Rachel Y Moon, MD University of Virginia
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rachel Moon, MD, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT01361880     History of Changes
Other Study ID Numbers: 2011-095
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017

Keywords provided by Rachel Moon, MD, University of Virginia:
African American
Anticipatory Guidance
Health Promotion
Infant Mortality
Injury Prevention
Parent Education
sudden Infant Death Syndrome

Additional relevant MeSH terms:
Infant Death
Pathologic Processes