PROSPECTIVE CLINICAL STUDIES IN NEONATAL SURGERY

新生儿外科的前瞻性临床研究

• 批准号: 6636742
• 负责人: MARTIN LEE BLAKELY
• 金额: $ 13.08万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-01 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6636742
• 关键词: clinical trials; colitis; experimental designs; gastrointestinal surgery; health care service evaluation; hernia; hospital length of stay; human subject; human therapy evaluation; infant human (0-1 year); infant mortality; intestines; low birth weight infant human; nutrition related tag; outcomes research; parenteral feedings; patient oriented research; pediatrics; postdoctoral investigator; postoperative complications; predoctoral investigator; surgery

DESCRIPTION (Adapted from applicant's description): The purpose of the career development activities described in this proposal is for Dr. Martin Blakely, a pediatric surgeon, to acquire the knowledge and skills required to conduct patient-oriented research of the highest quality. The candidate has a proven history of commitment to research during his surgical training. The institutional environment at UT Houston offers extensive resources available to the candidate, e.g. the Clinical Research Curriculum and Mentorship Program funded by an NIH K30 award and directed by the candidate's mentor. The career development plan includes formal mentorship, extensive coursework leading to a Master's of Science degree in clinical research, and participation in the NICHD Neonatal Research Network. Jon Tyson, M.D., M.P.H., is a renowned neonatologist and epidemiologist with extensive experience in clinical research study design and will serve as Dr. Blakely's primary mentor. Dr. Tyson also directs the Center for Population Health and Evidence-Based Medicine whose faculty members are available to the candidate. Kevin Lally, M.D., is a pediatric surgeon with experience in multi-center studies in this field and is the candidate's second mentor. Dr. Lally has established collaborative relationships with pediatric surgeons throughout the US that will facilitate the studies proposed by Dr. Blakely. There are four phases of the research plan. Initially, a series of systematic reviews of therapy for extremely low birthweight (ELBW) infants with necrotizing enterocolitis (NEC) will be completed and published in the Cochrane Library. Secondly, a multi- center prospective observational study documenting center variability and patient outcome after surgery for NEC in ELBW infants will be performed. The proposal for this study is under review by the NICHD Neonatal Research Network, of which Dr. Tyson is a principal investigator. A primary purpose of this study is to document the need for and to help design a randomized clinical trial described below. The third phase consists of completing an on-going randomized clinical trial comparing early versus late inguinal hernia repair in premature infants. And lastly, based on the results of the observational NEC study, it is anticipated that a randomized trial will be designed near the end of the award period to compare simple peritoneal drainage versus formal laparotomy in infants with NEC, which is a very controversial question in neonatal surgery.

描述（根据申请人的描述改编）：职业目的 本提案中描述的开发活动是针对 Martin Blakely 博士的， 小儿外科医生，获得进行手术所需的知识和技能 以患者为中心的最高质量的研究。 候选人已被证实 在他的外科训练期间致力于研究的历史。 这 UT休斯敦大学的机构环境提供了广泛的可用资源 给候选人，例如临床研究课程和指导计划 由 NIH K30 奖项资助并由候选人导师指导。 职业生涯 发展计划包括正式的指导、广泛的课程作业 临床研究理学硕士学位，并参与 NICHD 新生儿研究网络。 乔恩·泰森 (Jon Tyson)，医学博士、公共卫生硕士，是一位著名的 具有丰富临床经验的新生儿科医生和流行病学家 研究设计并将担任布莱克利博士的主要导师。 泰森博士还领导人口健康和循证中心 医学，其教员可供候选人使用。 凯文·拉利, 医学博士，是一位儿科外科医生，在这方面具有多中心研究经验 领域，是候选人的第二导师。 拉利博士建立了 与美国各地儿科外科医生的合作关系 将促进布莱克利博士提出的研究。 有四个阶段 研究计划。 最初，对治疗进行了一系列系统评价 患有坏死性小肠结肠炎 (NEC) 的极低出生体重 (ELBW) 婴儿 将在 Cochrane 图书馆完成并出版。 其次，多 中心前瞻性观察研究记录中心变异性和 将评估 ELBW 婴儿 NEC 手术后的患者结果。 这 NICHD 新生儿研究中心正在审查这项研究的提案 泰森博士是该网络的首席研究员。 一个主要目的 这项研究旨在记录随机试验的必要性并帮助设计 临床试验如下所述。 第三阶段包括完成 正在进行的比较早期与晚期腹股沟疝气的随机临床试验 早产儿的修复。 最后，根据调查结果 观察性 NEC 研究，预计将进行一项随机试验 设计于奖励期接近结束时，以比较简单的腹膜 对于患有 NEC 的婴儿，引流术与正式剖腹手术是一个非常重要的问题 新生儿手术中有争议的问题。