The NICHD invites applications from investigators willing to participate under a cooperative agreement in an ongoing multicenter international research network designed to perform randomized clinical trials of interventions to reduce the major risks to maternal, neonatal, infant, and early childhood health in resource-poor countries. The purpose of this solicitation is to complement the existing Global Network with the addition of research units (RUs) from Africa and India. The objective of this program is to contribute to the resolution of maternal and pediatric health problems by establishing a network of RUs (paired U.S.-based and foreign centers) that will use common protocols to implement randomized clinical trials and thus contribute to the evidence base for sound clinical, programmatic, and policy decisions. The network will establish the infrastructure necessary to initiate, implement, and evaluate randomized controlled trials in community settings and health care facilities among pregnant women, newborns, infants, and children to the age of 3 years.
The overall goal of the network is to expand scientific knowledge relevant to improving health outcomes for women and children in developing countries. Other critical goals are to: 1) develop sustainable research infrastructure and public health intervention capabilities in developing countries and 2) strengthen international collaborative research arrangements that focus on the leading causes of morbidity and mortality in pregnancy and early childhood. A key objective for the network RUs is to design, develop, and conduct multiple simultaneous common clinical trials, as well as to evaluate and implement evidence-based health interventions and pertinent formative and translational research studies collaboratively. These studies must have a strong scientific and epidemiologic basis for their use in a foreign country, and should be culturally appropriate. The primary end points in these studies must be associated with demonstrable improvement in important public health measures in the population under study. This network will bring the required numbers of subjects into rigorously designed common protocols and thus address pressing research questions in pregnant women and very young children more quickly and efficiently than could individual centers acting alone.
Research that is predominantly epidemiologic, such as observational or surveillance studies, will not be reviewed and will be returned to the PI as unresponsive to the RFA. Applications that propose only to evaluate health care delivery programs or health care utilization and do not evaluate a human experimental intervention will also be considered as non-responsive and will be returned without review. Program staff will assist the PIs and the SFIs of the Global Network for Women's and Children's Health Research (GN) to identify research topics of high priority, and to design, implement, and evaluate the impact of common protocols.
According to a report of the Global Forum for Health Research, > 1.3 billion of the approximately 6 billion people alive today live in extreme poverty. Nearly 3 billion people live on < $2 a day, and 70% of these poor are women. Frequently in poor health, they live in unsafe and unsanitary conditions, have the primary responsibility for caring for children and the elderly, and are often expected to perform the major tasks of family sustenance. Despite successes during the past 30 years in improving the health of women and children worldwide, interventions are needed to avert the continuing unnecessary, preventable deaths, illness, and disability that disproportionately affect poor women and children, especially in the developing world.
Problems at the home and community level contribute to maternal, neonatal, and child morbidity and mortality. These include underlying nutritional deficits, limited access to quality medical care, …