Multicenter Network of Neonatal Intensive Care Units

新生儿重症监护室多中心网络

基本信息

批准号：
8249423
负责人：
KATHLEEN A KENNEDY
金额：
$ 29.55万
依托单位：
UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-07-17 至 2016-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8249423
关键词：
Address Adherence Admission activity Age Area Bayesian Method Bioethics Biometry Birth Bronchopulmonary Dysplasia Caring Cause of Death Censuses Child Childhood Clinic Clinical Clinical Investigator Clinical Research Clinical Trials Clinical effectiveness Commit Complex Comprehensive Health Care Congenital Abnormality Consult County Hospitals Development Discipline Diuretics Effectiveness Engineering Enrollment Epidemiology Ethics Evaluation Evidence Based Medicine Evoked Potentials, Auditory, Brain Stem Faculty Family Funding Goals Health Health Services Research Healthcare Hispanics Hospitals Hour Infant Information Sciences Instruction Intervention Laparotomy Lead Length of Stay Link Liquid substance Long-Term Effects Low income Master&apos s Degree Medical center Mentors Methods Morbidity - disease rate Necrotizing Enterocolitis Neonatal Neonatal Intensive Care Units Neonatology Operative Surgical Procedures Outcome Patients Pediatric Surgical Procedures Phototherapy Play Population Premature Infant Prevention Principal Investigator Protocol Compliance Protocols documentation Public Health Nurses Public Health Nursing Randomized Clinical Trials Research Research Design Research Infrastructure Research Methodology Research Personnel Resources Role SECTM1 gene Safety Sample Size Schools Services Site Surgeon Survivors System Teaching Hospitals Texas Training Universities Vitamin A arm base cohort cost cost effective design dissemination research efficacy trial follow-up health care economics high risk infant improved innovation interest medical schools member multidisciplinary natural hypothermia new product development preference premature programs public health relevance racial and ethnic randomized trial satisfaction treatment effect

项目摘要

DESCRIPTION (provided by applicant): UT Houston has been a member of both the Neonatal and MFMU Networks since 2001. This renewal application for the Neonatal Network proposes to 1) contribute to the conduct of rigorously designed and executed clinical trials, 2) design and implement at least one major trial of an important management question in the NICU and one in the follow-up clinic, 3) advance the methods in clinical research involving preterm infants. The UT-Houston Network site provides: 1) A large and growing NICU population (9937 births and 1775 ICU admissions in 2009) with racial and ethnic diversity [30-38% Black, 12-31% White, 25- 46% Hispanic (ranges of two practice sites)], 2) High enrollment in Network studies (ranked 2nd and 6th of 16 centers in the two most recently completed large Network trials, 3) Skilled and committed PI and CoPI [Drs. Kennedy and Tyson have served as Pl and Co-PI for the past 19 years, 7 in Dallas and 12 at UT- Houston. Together, they direct the Center for Clinical Research and Evidence-Based Medicine and the Master's Degree Program in Clinical Research at UT-Houston. They are known in the Network for their commitment to rigorous research methods and for helping other investigators with study design. They have played major roles in the design and implementation of numerous completed and ongoing Network randomized trials (Vitamin A, Hypothermia, Phototherapy, Surgery for NEC).], 4) a large pool of talented collaborators to provide multidisciplinary expertise [Dr. Kevin Lilly (Chair of Pediatric Surgery) and Dr. Tyson mentored Dr. Martin Blakely (Pediatric Surgeon, now in Memphis) in developing the ongoing Surgery for NEC Trial. Dr. Nehal Parikh, a K23 awardee and mentee of Drs Kennedy and Tyson, directs the ongoing 6- 24 Hour Hypothermia Trial at our site. Dr. Claudia Pedroza is a statistician with institutional K12 funding to conduct Bayesian analyses of Network studies. This application includes a concept application of a pragmatic management trial to compare the clinical effectiveness, safety, and long-term effects of two commonly practiced but poorly studied management strategies in the NICU - aggressive diuretic and strict fluid restriction vs. restricted diuretic use for the prevention of bronchopulmonary dysplasia. PUBLIC HEALTH RELEVANCE (See instructions): In the US each year, approximately 400,000 infants are admitted to neonatal intensive care units because of prematurity or birth defects. Over the past several decades, clinical research has greatly improved the survival prospects for these infants, but many survivors have significant morbidity that persists into childhood and beyond. Ongoing pragmatic clinical research is needed to improve these outcomes.

描述（由申请人提供）：UT休斯顿自2001年以来一直是新生儿和MFMU网络的成员。该新生儿网络的这种更新应用建议提议1）为1）促进了严格设计和执行的临床试验，2）在NICU和一项临床中，在临床中进行了至少一个重要的管理问题的设计和实施一个重要的管理问题。 Ut-Houston网络网站提供：1）具有种族和种族多样性[30-38％的黑色，12-31％的白色，25-46％的西班牙裔西班牙裔（两个实践网站的范围）（两个练习网站），2）较大的网络研究（2），大多数较大的网络（2）（6 nd nefters 2nd and），较大的NICU人口（2009年9937个出生和1775 ICU入院）具有种族和种族多样性[30-38％，白色，25-46％的白色（25-46％）和6 nectect and Internect（2）。熟练和承诺的Pi和Copi [Drs。肯尼迪（Kennedy）和泰森（Tyson）在过去的19年中一直担任PL和Co-Pi，在达拉斯（Dallas）7岁，在乌特顿（Ut Houston）担任PL和Co-Pi。他们一起指导临床研究和循证医学中心以及UT-Houston临床研究硕士学位课程。他们在网络中以对严格的研究方法的承诺以及帮助其他研究人员进行研究设计而闻名。他们在众多完整和正在进行的网络随机试验的设计和实施中发挥了重要作用（维生素A，体温过低，光疗，NEC手术，NEC手术）。凯文·莉莉（Kevin Lilly）（儿科手术主席）和泰森（Tyson）博士指导了马丁·布拉克利（Martin Blakely）博士（现在是孟菲斯的儿科外科医生）开发了正在进行的NEC试验手术。肯尼迪博士和泰森博士的K23获奖者和受训者Nehal Parikh博士指导我们现场正在进行的6至24小时低温试验。 Claudia Pedroza博士是一位统计学家，拥有机构K12资金，以进行贝叶斯研究分析。该应用程序包括一项务实管理试验的概念应用，以比较两种常见但经过研究不足的管理策略在NICU中的临床有效性，安全性和长期影响 - 侵略性的利尿剂和严格的流体限制与受限的利尿剂用于预防支气管肺发育不良的利尿剂。公共卫生相关性（请参阅说明）：每年在美国，由于早产或出生缺陷，大约有40万婴儿被接纳为新生儿重症监护病房。在过去的几十年中，临床研究大大改善了这些婴儿的生存前景，但是许多幸存者具有明显的发病率，可以持续到童年及以后。需要持续的务实临床研究来改善这些结果。