Reduce African-American Infant Mortality

NCT01361880 | Completed

• 1 other identifier: 2011-095
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

African American; Anticipatory Guidance; Health Promotion; Infant Mortality; Injury Prevention; Nurses; Parent Education; sudden Infant Death Syndrome

Outcome Measures

Primary Outcomes (1)

• Suffocation, Strangulation and Sudden Infant Death Syndrome

  Sleep Position (Supine vs. Nonsupine) Bedsharing (Yes vs. No) Use of Softbedding (Yes vs. No)

  Three years

Study Arms (1)

Reduce infant mortality

OTHER

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

Interventions

Reduce Infant Mortality BEHAVIORAL

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.

Also known as: African Americans, Anticipatory guidance, Health Promotion, Infant Mortality, Injury Prevention, Nurses, Parent Education, Sudden Infant Death Syndrome

Reduce infant mortality

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• Children's National Research Institute: collaborator
• Medstar Health Research Institute: collaborator

Study Sites (1)

Washington Hospital Center

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

Location

Related Publications (2)

• 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.

  PMID: 27470122 DERIVED

• 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.

  PMID: 27263400 DERIVED

MeSH Terms

Conditions

Health Behavior; Infant Death; Sudden Infant Death

Interventions

Health Promotion; Infant Mortality; Nurses

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Mortality; Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Health Personnel

Study Officials

• Rachel Y Moon, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• 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: June 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 5, 2017

Record last verified: 2017-06

Locations

US (1)