PROSPECTIVE CLINICAL STUDIES IN NEONATAL SURGERY

新生儿外科的前瞻性临床研究

• 批准号: 6927897
• 负责人: MARTIN LEE BLAKELY
• 金额: $ 13.08万
• 依托单位: UNIVERSITY OF TENNESSEE HEALTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6927897
• 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; necrotizing enterocolitis; 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（改编自申请人描述）：职业生涯的目的