Research Triangle Institute (RTI) proposes to serve as the Data Coordinating Center (DCC) for the NICHD Global Network for Women's and Children's Health Research (GN). The strong, experienced team of scientists who have led the GN DCC for the past 5 years will continue this effort. Responsibilities of the DCC will include (1) coordinating overall study activities;(2) providing biostatistical and data management leadership;(3) participating in study design and protocol development;(4) developing data management systems (DMSs);(5) collaborating in developing study materials (e.g., data forms) and overseeing translation of these materials into appropriate languages;(6) developing and implementing quality control systems;(7) assisting in training Research Unit (RU) personnel in study procedures, including use of the DMSs;(8) developing capacity for research at the RUs by training RU staff in research methodology, data management, and statistical analysis and assisting them in writing DMSs and in publishing study results;(9) continuing to manage study-wide communications and logistics;(10) assisting RUs (if appropriate) in biological specimen collection;(11) organizing and coordinating Steering Committee (SC) and Data and Safety Monitoring Board (DSMB) meetings;(12) producing routine and special reports that meet the needs of the RUs, NICHD, the SC, and the DSMB;and (13) assisting in disseminating results of the GN studies through publication and presentations. All proposed RTI staff have been involved in carrying out the above responsibilities for the GN, including the PI, Tyler Hartwell, Ph.D., and Co-Pis Vijaya Rao, Ph.D., and Elizabeth McClure, M.Ed. Drs. Hartwell and Rao each have over 30 years of experience in leading DCCs for NIH multicenter studies, including international studies. We will use an Internal Management Committee to oversee the DCC operations and assign a DCC Protocol Team to work with GN investigators on each new protocol. We will use the existing IT structures, developed over the past 5 years, to collect and transmit study data to RTI from RU sites continuing in the Network, including hardware, software, and the on-site IT expert and data manager to assist in maintaining the systems. For new RUs, we will assist in purchasing the computer equipment required for data collection, management, and transmission and will help train new RU site staff to manage the systems developed. Our communications network will again be built around conference calls, e-mail, and the project website that disseminates project reports and study materials. During the first year of the project, RTI will collaborate with RU staff and NICHD to finish publications from single site protocols from the first phase of the study, complete data collection on the FIRST BREATH multicenter protocol, and begin developing additional common protocols for randomized clinical trials.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HD040636-11
Application #
8070419
Study Section
Special Emphasis Panel (ZHD1-MCHG-B (25))
Program Officer
Wright, Linda
Project Start
2001-08-17
Project End
2012-04-30
Budget Start
2011-05-01
Budget End
2012-04-30
Support Year
11
Fiscal Year
2011
Total Cost
$1,318,942
Indirect Cost
Name
Research Triangle Institute
Department
Type
DUNS #
004868105
City
Research Triangle
State
NC
Country
United States
Zip Code
27709
McClure, E M; Garces, A; Saleem, S et al. (2018) Global Network for Women's and Children's Health Research: probable causes of stillbirth in low- and middle-income countries using a prospectively defined classification system. BJOG 125:131-138
Goldenberg, Robert L; Saleem, Sarah; Ali, Sumera et al. (2017) Maternal near miss in low-resource areas. Int J Gynaecol Obstet 138:347-355
Nathan, Robert O; Swanson, Jonathan O; Swanson, David L et al. (2017) Evaluation of Focused Obstetric Ultrasound Examinations by Health Care Personnel in the Democratic Republic of Congo, Guatemala, Kenya, Pakistan, and Zambia. Curr Probl Diagn Radiol 46:210-215
Swanson, David; Lokangaka, Adrien; Bauserman, Melissa et al. (2017) Challenges of Implementing Antenatal Ultrasound Screening in a Rural Study Site: A Case Study From the Democratic Republic of the Congo. Glob Health Sci Pract 5:315-324
Harrison, Margo S; Pasha, Omrana; Saleem, Sarah et al. (2017) A prospective study of maternal, fetal and neonatal outcomes in the setting of cesarean section in low- and middle-income countries. Acta Obstet Gynecol Scand 96:410-420
Madhani, Farhana I; Karmaliani, Rozina; Patel, Cyra et al. (2017) Women's Perceptions and Experiences of Domestic Violence: An Observational Study From Hyderabad, Pakistan. J Interpers Violence 32:76-100
Garces, Ana L; McClure, Elizabeth M; PĂ©rez, Wilton et al. (2017) The Global Network Neonatal Cause of Death algorithm for low-resource settings. Acta Paediatr 106:904-911
Bang, Akash; Patel, Archana; Bellad, Roopa et al. (2016) Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time? BMC Pregnancy Childbirth 16:364
Bellad, Roopa M; Bang, Akash; Carlo, Waldemar A et al. (2016) A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: does Helping Babies Breathe training save lives? BMC Pregnancy Childbirth 16:222
McClure, Elizabeth M; Goldenberg, Robert L; Jobe, Alan H et al. (2016) Reducing neonatal mortality associated with preterm birth: gaps in knowledge of the impact of antenatal corticosteroids on preterm birth outcomes in low-middle income countries. Reprod Health 13:61

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