Reduce African-American Infant Mortality (SIDS)
Primary Purpose
Health Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduce Infant Mortality
Sponsored by
About this trial
This is an interventional health services research trial for Health Behavior focused on measuring African American, Anticipatory Guidance, Health Promotion, Infant Mortality, Injury Prevention, Nurses, Parent Education, sudden Infant Death Syndrome
Eligibility 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.
Sites / Locations
- Washington Hospital Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Reduce infant mortality
Arm Description
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
Outcomes
Primary Outcome Measures
Suffocation, Strangulation and Sudden Infant Death Syndrome
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)
Secondary Outcome Measures
Full Information
NCT ID
NCT01361880
First Posted
May 12, 2011
Last Updated
June 30, 2017
Sponsor
University of Virginia
Collaborators
Children's National Research Institute, Medstar Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01361880
Brief Title
Reduce African-American Infant Mortality
Acronym
SIDS
Official Title
Randomized Messaging Trial to Reduce African-American Infant Mortality
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Children's National Research Institute, Medstar Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior
Keywords
African American, Anticipatory Guidance, Health Promotion, Infant Mortality, Injury Prevention, Nurses, Parent Education, sudden Infant Death Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reduce infant mortality
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Reduce Infant Mortality
Other Intervention Name(s)
African Americans, Anticipatory guidance, Health Promotion, Infant Mortality, Injury Prevention, Nurses, Parent Education, Sudden Infant Death Syndrome
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suffocation, Strangulation and Sudden Infant Death Syndrome
Description
Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Y Moon, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27470122
Citation
Moon RY, Mathews A, Joyner BL, Oden RP, He J, McCarter R. Health Messaging and African-American Infant Sleep Location: A Randomized Controlled Trial. J Community Health. 2017 Feb;42(1):1-9. doi: 10.1007/s10900-016-0227-1.
Results Reference
derived
PubMed Identifier
27263400
Citation
Mathews A, Joyner BL, Oden RP, He J, McCarter R Jr, Moon RY. Messaging Affects the Behavior of African American Parents with Regards to Soft Bedding in the Infant Sleep Environment: A Randomized Controlled Trial. J Pediatr. 2016 Aug;175:79-85.e2. doi: 10.1016/j.jpeds.2016.05.004. Epub 2016 Jun 2.
Results Reference
derived
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Reduce African-American Infant Mortality
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