Reduce African-American Infant Mortality (SIDS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by Children's Research Institute
Sponsor:
Collaborator:
Washington Hospital Center
Information provided by (Responsible Party):
Rachel Moon, Children's Research Institute
ClinicalTrials.gov Identifier:
NCT01361880
First received: May 12, 2011
Last updated: September 9, 2014
Last verified: January 2012
  Purpose

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 Intervention
Health Behavior
Behavioral: Randomized Messaging Trial

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Messaging Trial to Reduce African-American Infant Mortality

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

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


Estimated Enrollment: 990
Study Start Date: June 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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: Randomized Messaging Trial
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.
Other Names:
  • African Americans
  • Anticipatory guidance
  • Health Promotion
  • Infant Mortality
  • Injury Prevention
  • Nurses
  • Parent Education
  • Sudden Infant Death Syndrome
Behavioral: Randomized Messaging Trial
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 obtain for each of the participants to facilitate study follow-up within two weeks of their infants birth, when the infant is 2-3 months old and when the infant is 5-6 months old. Participants will be provided with written and verbal safe sleep information.
Other Names:
  • African American
  • Anticipatory Guidance
  • Health Promotion
  • Infant Mortality
  • Injury Prevention
  • Nurses
  • Parent Education
  • Sudden Infant Death Syndrome

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361880

Contacts
Contact: Rosalind P Oden 202-476-3113 rpoden@cnmc.org

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Rita Driggers, MD    202-877-3068    rita.w.driggers@medstar.net   
Contact: Rosalind P Oden    202-476-3113    rpoden@cnmc.org   
Sponsors and Collaborators
Children's Research Institute
Washington Hospital Center
Investigators
Principal Investigator: Rachel Y Moon, MD Children's Research Institute
  More Information

No publications provided

Responsible Party: Rachel Moon, Principal Investigator, Children's Research Institute
ClinicalTrials.gov Identifier: NCT01361880     History of Changes
Other Study ID Numbers: 2011-095
Study First Received: May 12, 2011
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
African American
Anticipatory Guidance
Health Promotion
Infant Mortality
Injury Prevention
Nurses
Parent Education
sudden Infant Death Syndrome

ClinicalTrials.gov processed this record on September 30, 2014