Reduce African-American Infant Mortality (SIDS)
| Tracking Information | |||||
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| First Received Date ICMJE | May 12, 2011 | ||||
| Last Updated Date | January 17, 2012 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01361880 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Reduce African-American Infant Mortality | ||||
| Official Title ICMJE | Randomized Messaging Trial to Reduce African-American Infant Mortality | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Health Behavior | ||||
| Intervention ICMJE |
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| Study Arm (s) | 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
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 990 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01361880 | ||||
| Other Study ID Numbers ICMJE | 2011-095 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rachel Moon, Children's Research Institute | ||||
| Study Sponsor ICMJE | Children's Research Institute | ||||
| Collaborators ICMJE | Washington Hospital Center | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Research Institute | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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