AMENDMENT TO RFA-HD-02-025, RESEARCH ON THE SCOPE AND CAUSES OF STILLBIRTH IN THE UNITED STATES RELEASE DATE: January 29, 2003 NOTICE: NOT-HD-03-008 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) The National Institute of Child Health and Human Development (NICHD) is publishing this notice to clarify several requirements for applications responding to NICHD Request for Applications RFA-HD-02-025, RESEARCH ON THE SCOPE AND CAUSES OF STILLBIRTH IN THE UNITED STATES (http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-02-025.html). The following information reiterates and expands on the RFA language regarding the objectives and requirements for a geographic population- based study of stillbirth. (1) As stated in the RFA, the second research objective is to: "obtain a geographic population-based determination of the incidence of fetal deaths at 20 weeks gestation or greater, their causes, and risk factors. This will involve a geographic population-based study of stillbirths enrolled at the time of demise, and a sub-cohort case- control study." (2) In order to achieve this objective, the project organization will be developed post-award as stated in the RFA as follows: "The grantees will form a cooperative network in scientific partnership with NICHD to conduct a geographic population-based study of stillbirths, which will require a highly effective surveillance system, and at least 90 percent ascertainment." Thus, a "geographic population-based study of stillbirths enrolled at the time of demise" means that within a geographic area, the investigative team should have the capability to have at least 90 percent case ascertainment in real time of women living in the geographic area, and to capture information on at least 90 percent of all the pregnancies (ending in live- or stillbirth) occurring to the women living in the geographic area. The boundaries of the geographic catchment must be able to be drawn on a map. (3) As a starting point, the applicant is required to define the minimum geographic catchment as described in the RFA as follows: "Minimum Catchment Populations: Clinical Sites with urban populations should have a catchment population with at least 8,000 deliveries per year, and those with rural populations at least 3,000 deliveries per year in order to apply. Applicants may propose urban only, rural only, or urban and rural geographic areas for case ascertainment. The applicant must demonstrate that a large majority of the population receives prenatal care within the catchment." (4) Thus, the applicant must provide the following information in the application as delineated under Supplemental Instructions in the RFA: "(1) Patient population o Geographic definition of the catchment area proposed for a population-based assessment of stillbirths by the applicant organization. o Documentation of number of deliveries at or later than 20 weeks within the catchment geographic population from 1995-1999 to include: (a) each pregnancy outcome (fetal death, live birth,) stratified by race/ethnicity; (b) each pregnancy outcome stratified by gestational age (20-23 weeks, 24-27 weeks, 28-31 weeks, 32-36 weeks, 37 plus weeks); (c) proportion receiving prenatal care within the catchment stratified by trimester. o Estimated rates of fetal deaths at or later than 20 weeks per 1000 live births plus stillbirths, and rates of fetal autopsy and placental pathology from 1995-1999. o Distribution of causes of fetal deaths at or later than 20 weeks from 1995-1999." It is recognized that interested potential applicants may not have a geographically-based system of prenatal care delivery or stillbirth surveillance in place, and that collaborations will have to be developed to respond to the RFA. This is delineated under Supplemental Instructions in the RFA as follows: "(2) Staffing and Procedures o Descriptions of the staff and programs in place for surveillance of deliveries in the catchment area to identify all eligible fetal deaths at or later than 20 weeks, and proposals for expansion of services if needed. This includes creative proposals for partnering with community-based organizations including health departments." INQUIRIES For further information, contact: Marian Willinger Special Assistant for SIDS National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6896 Fax: (301) 496-3790 Email: willingm@mail.nih.gov
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