MULTICENTER NETWORK OF NEONATAL INTENSIVE CARE UNITS

新生儿重症监护病房的多中心网络

• 批准号: 3560146
• 负责人: JON E. TYSON
• 金额: $ 16.98万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-04-01 至 1996-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3560146
• 关键词: child physical development; clinical trials; cooperative study; developmental nutrition; female; human pregnant subject; human subject; human therapy evaluation; infant human (0-1 year); infant mortality; longitudinal human study; low birth weight infant human; mother /infant health care; neonatal intensive care; newborn human (0-6 weeks); nursery; nutrition related tag; obstetrics; perinatal; premature infant human; respirators

This proposal is to request continued participation of UT Southwestern in the Cooperative Neonatal Network. With an expansion from 2 to 3 hospitals, our population will include approximately 22,500 births per year and 365 infants < 1500 g. The addition of the third hospital provides a primarily middle class, caucasian population which has been underrepresented in Network studies. Major strengths of our center demonstrated in the first 5 years include the ability to enroll large numbers of infants in the Network trials (the second greatest enrollment of the participating centers), timely data collection (with submission of major data forms in a shorter interval than in all but one small center), and the contributions of the PI and Co-PI (who have separately chaired 3 committees and drafted the protocol for the next major clinical trial slated for the Network). The PI as director of the Perinatal Epidemiology Program at UT Southwestern is particularly committed to clinical trials and has participated effectively in such demanding multi-center trials as the Infant Health and Development Program. The obstetric consultant is Director of the Maternal Fetal Medicine training program in an eminent Department of Obstetrics. The quality of the follow-up program and our ability to design and conduct major clinical trials is reflected our trial to determine whether primary follow-up care reduces the mortality of indigent very low birth weight risk infants after discharge from the nursery by 50% and total days of pediatric intensive care by 33% (sample size - 762 infants; approximately 250 enrolled to date). Based on our experience in the Network and participation in the editorial board of the National Perinatal Epidemiology Unit (Oxford, England) which has been extraordinarily successful in conducting multi-center perinatal trials at relatively low cost, we suggest a number of methods to augment the cost effectiveness of the Network. These include 1) careful assessment of the amount of generic data to collect; 2) consideration of factorial designs to answer more questions with greater clarity with the same number of patients 3) consideration of modified consent procedures when treatment risk is not increased above that experienced clinically and when parental comprehension is compromised during labor or the early neonatal period, and 4) in relatively uncomplicated trials, involvement of patients in nonuniversity hospitals to increase sample size and generalizability of results.

该建议是要求UT西南部继续参与 合作新生儿网络。 随着2家医院的扩展， 我们的人口每年将包括大约22,500个出生和365个 婴儿<1500 g。第三次医院的增加主要提供 中产阶级，高加索人口的代表性不足 网络研究。 我们中心的主要优势在第一个 5年包括参加大量婴儿的能力 网络试验（参与的第二大入学率 中心），及时的数据收集（在提交主要数据表格中 除一个小中心以外的所有中心都短的间隔）和贡献 PI和Co-Pi（分别主持了3个委员会并起草 下一个主要临床试验的方案计划于网络）。 PI担任UT西南部围产期流行病学计划的主任 特别致力于临床试验，并参与了 在此类苛刻的多中心试验中有效地有效 发展计划。 产科顾问是孕产妇的主任 著名妇产科部门的胎儿医学培训计划。 后续计划的质量以及我们设计和进行的能力 主要的临床试验反映了我们的试验，以确定主要的 后续护理降低了贫困非常低的出生体重风险的死亡率 从托儿所出院后的婴儿50％，小儿总天数 重症监护33％（样本量-762个婴儿；约250 注册至今）。 根据我们在网络中的经验， 参加国家围产期流行病学编辑委员会的编辑委员会 单位（英格兰牛津）在 我们建议以相对较低的成本进行多中心的围产期试验 许多方法来增强网络的成本效益。 其中包括1）仔细评估通用数据的数量 收集; 2）考虑阶乘设计以回答更多问题 具有相同数量的患者的更清晰度3）考虑 当治疗风险没有增加以上时，修改的同意程序 在临床上经历了经验时，当父母理解被妥协时 在分娩或新生儿早期，4）相对 简单的试验，患者参与非大学医院 增加样本量和结果的普遍性。