Zika in Pregnancy Supplemental Funding request

怀孕期寨卡补充资金请求

• 批准号: 9473168
• 负责人: Elizabeth M McClure
• 金额: $ 40万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-17 至 2018-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9473168
• 关键词: Address; Adrenal Cortex Hormones; Child; Child health care; Childhood; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Computer software; Computers; Country; Cultural Diversity; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Developing Countries; Development; Discipline of obstetrics; Electronic Mail; Emergency Situation; Ensure; Environment; Equipment; Equipment and Supplies; Ethical Issues; Exhibits; Foundations; Funding; Funding Agency; Goals; Health; Individual; Information Systems; International; Internet; Leadership; Logistics; Manuscripts; Maps; Mission; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; National Institute of Child Health and Human Development; Newborn Infant; Participant; Performance; Pharmaceutical Preparations; Phonation; Pregnancy; Productivity; Protocols documentation; Public Health; Publications; Publishing; Randomized; Recording of previous events; Recruitment Activity; Registries; Reporting; Research; Research Design; Research Personnel; Resolution; Resources; Safety; Secure; Services; Site; System; Telephone; Time; Training; Woman; Women' s Health; Zika Virus; antenatal; clinically relevant; data management; design; distributed data; drug distribution; editorial; experience; flexibility; human subject protection; improved; innovation; low income country; meetings; member; minority children; mortality; neonatal care; operation; public health relevance; rural area; social media; sound; symposium; tool; transmission process; web site

DESCRIPTION (provided by applicant): RTI International (RTI), as the proposed data coordinating center (DCC) for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network (GN), will provide the scientific and operational resources to maximize the scientific productivity and public health impact of the GN research collaborations across diverse research settings in multiple low-income countries. To achieve this aim, RTI will (1) provide scientific and statistical leadership to facilitate feasible, scientificaly sound, and clinically relevant protocols; (2) develop and support innovative, robust, secure, and locally sustainable data management systems (DMSs) that enhance the implementation of the study protocols and increase local research capacity; (3) develop effective data monitoring and safety reports that facilitate study management and oversight; (4) facilitate collaborative, high-quality GN study publications through rigorous analyses and logistical and editorial support; (5) coordinate the acquisition, storage, and tracking of study drugs, equipment, and supplies; and (6) promote efficient study development and implementation through logistical communication support of the GN protocol teams and the External Advisory Board and the Data Safety and Monitoring Board. RTI brings specific strengths that will support the GN's mission to enhance the global research capacity to improve health of women and children in low-income countries: (1) proven scientific collaboration in the leadership of the GN over the past 11 years as demonstrated by the more than 110 collaborative GN manuscripts and the collaboration of E. McClure in extending GN capacity through collaboration with external funding sources; (2) a set of state-of-the art, flexible, established distributed data entry and management tools that will (a ensure high-quality data with rapid error resolution, (b) provide creative solutions to difficult problems like drug distribution in rural areas, and (c) provide site staff with study management and reporting tools that enhance the scientific quality; and (3) statistical expertise in study design that has provided the GN with innovative cluster- and individually randomized designs and quality improvement approaches that address the unique scientific, implementation, cultural, and ethical issues encountered by the GN.

描述（由申请人提供）：RTI International（RTI）作为尤尼斯·肯尼迪·施莱佛国家儿童健康与人类发展研究所（NICHD）全球网络（GN）的拟议数据协调中心（DCC），将提供科学和运营资源，以最大限度地提高GN研究合作在多个低收入国家不同研究环境中的科学生产力和公共卫生影响。为了实现这一目标，RTI将（1）提供科学和统计领导，以促进可行的、科学合理的和临床相关的协议;（2）开发和支持创新的、强大的、安全的和本地可持续的数据管理系统（DMS），以加强研究协议的实施并提高本地研究能力;（3）制定有效的数据监测和安全性报告，促进研究管理和监督;（4）通过严格的分析和后勤及编辑支持，促进协作性高质量GN研究出版物;（5）协调研究药物、设备和供应品的采购、储存和跟踪;以及（6）通过GN方案团队和外部咨询委员会以及数据安全和监测委员会的后勤通信支持，促进有效的研究开发和实施。RTI带来了具体的优势，将支持全球网络的使命，以提高全球研究能力，改善低收入国家妇女和儿童的健康：（1）在过去的11年中，全球网络的领导证明了110多个合作的全球网络手稿和E.麦克卢尔通过与外部资金来源合作，扩大全球网络的能力;（2）一套先进、灵活、成熟的分布式数据输入和管理工具，（a）确保高质量数据，并迅速解决错误，（B）为农村地区的药物分配等难题提供创造性解决办法，以及（c）为研究中心工作人员提供研究管理和报告工具，以提高科学质量;以及（3）研究设计方面的统计专业知识，为GN提供了创新的集群-以及个体随机设计和质量改进方法，以解决GN遇到的独特的科学、实施、文化和伦理问题。

项目成果

Evaluating time between birth to cry or bag and mask ventilation using mobile delivery room timers in India: the NICHD Global Network's Helping Babies Breathe Trial.

• DOI: 10.1186/s12887-015-0408-6
• 发表时间: 2015-08-06
• 期刊: BMC pediatrics
• 影响因子: 2.4
• 作者: Somannavar MS;Goudar SS;Revankar AP;Moore JL;McClure EM;Destefanis P;DeCain M;Goco N;Wright LL
• 通讯作者: Wright LL

An epidemiological study of urban and rural children in Pakistan: examining the relationship between delayed psychomotor development, low birth weight and postnatal growth failure.

巴基斯坦城乡儿童流行病学研究：考察精神运动发育迟缓、低出生体重和产后生长障碍之间的关系。

• DOI: 10.1093/trstmh/tru162
• 发表时间: 2015
• 期刊: Transactions of the Royal Society of Tropical Medicine and Hygiene
• 影响因子: 2.2
• 作者: Avan,BilalI;Raza,SyedA;Kirkwood,BettyR
• 通讯作者: Kirkwood,BettyR

Episiotomy rates from eleven developing countries.

十一个发展中国家的会阴切开术率。

• DOI: 10.1016/j.ijgo.2005.07.013
• 发表时间: 2005
• 期刊: International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics
• 作者: Kropp,N;Hartwell,T;Althabe,F
• 通讯作者: Althabe,F

Maternal heart rate patterns in the first and second stages of labor.

第一产程和第二产程的产妇心率模式。

• DOI: 10.1111/j.1600-0412.2012.01371.x
• 发表时间: 2012
• 期刊: Acta obstetricia et gynecologica Scandinavica
• 影响因子: 4.3
• 作者: VANVeen,TeelkienR;Belfort,MichaelA;Kofford,Shalece
• 通讯作者: Kofford,Shalece

Establishment of a Maternal Newborn Health Registry in the Belgaum District of Karnataka, India.

• DOI: 10.1186/1742-4755-12-s2-s3
• 发表时间: 2015
• 期刊: Reproductive health
• 影响因子: 3.4
• 作者: Kodkany BS;Derman RJ;Honnungar NV;Tyagi NK;Goudar SS;Mastiholi SC;Moore JL;McClure EM;Sloan N;Goldenberg RL
• 通讯作者: Goldenberg RL