Program seeks approval of the concept for an initiative titled, Re-competition of the Global Network Clinical Sites for Women’s and Children’s Health Research Program. This initiative will involve research focused on improved pregnancy outcomes for populations at risk in low resource settings.
In spite of remarkable advances in perinatal and pediatric care elsewhere, the highest global burden of maternal and infant mortality remains in sub-Saharan and South Asian populations. Over two-thirds the global burden of perinatal mortality (from stillbirths, maternal and infant deaths) occur in these regions in the world. To address this global health issue, the NICHD established a network of global health research in 2001 to conduct observational and randomized controlled clinical trials in these regions of high risk populations. More than 20 applications were received in response to the FOAs; 10 research units in 2007 and seven sites in 2012 have been funded. There have been 15 individual, and five multi-site protocol-based studies fielded and completed thus far by the Global Network for Women’s and Children’s Health Research Network (GN). A range of topics related to maternal and newborn health have been addressed by the GN sites, the results of which have had major impact on health outcomes globally. The randomized trials have included interventions to reduce postpartum hemorrhage, resuscitation practices to reduce neonatal mortality related to perinatal asphyxia, antenatal corticosteroids to reduce pulmonary morbidity associated with preterm birth, and nutritional interventions to reduce stunting and improve infant growth, among others. The results from GN trials led the World Health Organization (WHO) to make many practice recommendations, such as using misoprostol universally to reduce postpartum hemorrhage, which is now a standard therapy in low-resource settings. The recent findings of higher mortality due to exposure to antenatal corticosteroids (ANC) led the WHO to reevaluation the planned, widespread ANC intervention, and to reassess the population-specific risks from this therapy to enhance fetal pulmonary maturity. In 2015, the Zambian Government credited that the GN-based research activities were the main reasons for the overall improvement in their national perinatal outcomes including the rates of stillbirths, and maternal and neonatal mortalities.
In spite of these remarkable advances, much remains to be done globally, to meet the United Nation’s Millennium Developmental goals initiated in 2000. A network of experts can field multi-center research activities using common protocols and infrastructure, and enroll large numbers of participants over shorter durations of time rather than individual sites requesting for single RCTs through other grant mechanisms. The network with its interdisciplinary expertise, yet focused approaches to be proposed by the GN is ideal, because of reduced costs and high global impact. This approach will also allow for one to explore the basis for regional variations in responses to “standard therapies.” Thus, we request the Council approval for developing the FOAs that will help to conduct cost-effective, high impact, multi –center, large scale research studies (observational and interventional) targeted at understanding the best methods to reduce maternal and infant mortality and morbidity globally. These goals are within the broader NICHD Scientific Vision.
Pregnancy and Perinatology Branch
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