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: [email protected]
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