NEONATAL SURGICAL DATABASE: NECROTIZING ENTEROCOLITIS (NEC) PROTOCOL

新生儿外科数据库：坏死性小肠结肠炎 (NEC) 方案

• 批准号: 8356658
• 负责人: MARY L BRANDT
• 金额: $ 0.53万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356658
• 关键词: Admission activity; Antibiotic Therapy; Antibiotics; Cardiovascular system; Caring; Case Series; Case Study; Cessation of life; Child; Child Care; Childhood; Clinical; Clinical Research; Data; Data Analyses; Data Collection; Databases; Deficiency Diseases; Deterioration; Diagnosis; Disease; Disease Progression; Emergency Situation; Enteral Feeding; Funding; Gastrointestinal Diseases; Grant; Incidence; Infant; Inflammatory disease of the intestine; Institutes; Institution; Intervention; Intestines; Lead; Life; Liquid substance; Literature; Live Birth; Low Birth Weight Infant; Malnutrition; Measures; National Center for Research Resources; Natural History; Necrosis; Necrotizing Enterocolitis; Neonatal; Neonatal Intensive Care Units; Newborn Infant; Operative Surgical Procedures; Oral; Outcome; Patients; Perforation; Physicians; Premature Infant; Principal Investigator; Prospective Studies; Protocols documentation; Reporting; Research; Research Infrastructure; Resources; Rest; Resuscitation; Risk Factors; San Francisco; Sepsis; Source; Stomach; Surgeon; United States; United States National Center for Health Statistics; United States National Institutes of Health; Universities; Very Low Birth Weight Infant; base; cohort; cost; feeding; high risk; operation; premature; prospective

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. HYPOTHESIS I. The prospective collection of data on a large cohort of premature infants with necrotizing enterocolitis (NEC) will accurately define the natural history of this devastating disease. These data will also permit definition of risk factors for developing severe NEC and the outcome of current practices in the treatment of NEC. II. SPECIFIC AIMS Specific Aim 1: To determine the risk factors for patients with NEC to progress to perforation or necrosis requiring surgical intervention. Specific Aim 2: To determine the relationship between feeding practices and the progression of NEC. Specific Aim 3: To determine the relationship between feeding regarding type and duration of antibiotic therapy in patients with non-surgical NEC in order to determine its impact on disease progression. Specific Aim 4: To determine the disease and patient specific factors that predict the occurrence of long-term nutritional deficiency and gastrointestinal disease. III. BACKGROUND AND SIGNIFICANCE Pediatric surgeons often care for children with uncommon diseases. This is particularly true of major neonatal surgical disorders such as Necrotizing Enterocolitis (NEC). Even a major pediatric referral center will not see an adequate number of patients to meaningfully assess outcomes from the institution's treatment approach. For this reason, the scientific literature on the care of children with NEC is almost exclusively comprised of anecdotal case reports and single-institution case-series data. The Glaser Research Network was established in 2001 to coordinate data collection between 6 institutions (Baylor, Harvard, University of San Francisco, Stanford, USC, UCLA). By combining data from these 6 institutions on infants with NEC a more meaningful analysis can be carried out. Necrotizing Enterocolitis is a severe inflammatory disease of the intestine that occurs in premature and low birth weight infants. First described in the 1060's, NEC is now the most common surgical emergency in the newborn infant. The incidence of NEC is reported to be from 1% to 5% of neonatal intensive care unit (NICU) admissions or 1 to 3 cases per 1,000 live births. Based upon analysis of data from the National Center for Health Statistics and multi-center trials, there are about 10,000 cases of NEC per year in the United States. This results in approximately 2500 deaths per year. The incidence of NEC correlates strongly with the degree of prematurity. It is these very low birth weight babies that present the physician with the greatest clinical challenge. Since successful treatment of NEC typically results in the child being able to lead a healthy and fully productive life, improvements in care can produce a tremendous impact in terms of number of years of life saved. The clinical presentation of NEC can range from feeding intolerance to severe sepsis with cardiovascular collapse. No definitive treatment for NEC exists. Most cases respond to discontinuation of oral feedings with nasogastric decompression, fluid resuscitation, broad-spectrum antibiotics, and other supportive measures. Severe NEC can result in intestinal necrosis and perforation. When these conditions occur, surgical intervention is necessary. Once the diagnosis of NEC is made, standard of practice is to institute bowel rest, gastric decompression, and broad spectrum antibiotics. Many patients respond well to this treatment and recover with no further intervention. Others deteriorate and develop intestinal necrosis or perforation requiring urgent operation. There is little available evidence to suggest what factors may help predict which infants are most likely to deteriorate. To date, no large prospective studies have followed infants diagnosed with NEC and determined their course. Identification of risk factors for deterioration could allow more intensive therapy to be focused on those most likely to benefit. In addition, such data could allow a more rapid return to enteral feeding and routing neonatal care for those not at high risk.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 假设 I.预期收集大量的早产婴儿，死灵性小肠结肠炎（NEC）将准确定义这种毁灭性疾病的自然历史。 这些数据还将允许定义开发严重NEC的危险因素以及当前实践在治疗NEC中的结果。 ii。 具体目标 特定目的1：确定NEC患者需要手术干预的穿孔或坏死患者的危险因素。 特定目的2：确定喂养实践与NEC的进展之间的关系。 具体目的3：确定非手术NEC患者的抗生素治疗类型和持续时间的喂养之间的关系，以确定其对疾病进展的影响。 特定目的4：确定预测长期营养缺乏和胃肠道疾病的疾病和患者特定因素。 iii。 背景和意义 小儿外科医生经常照顾罕见疾病的儿童。 对于新生儿手术疾病（例如坏死性小肠结肠炎（NEC）），尤其如此。 即使是主要的儿科转诊中心也不会看到足够数量的患者从机构的治疗方法中评估结果。 因此，关于NEC儿童护理的科学文献几乎完全由轶事案例报告和单一机构的病例系列数据组成。 Glaser研究网络成立于2001年，旨在协调6个机构之间的数据收集（贝勒，哈佛大学，旧金山大学，斯坦福大学，加州大学洛杉矶分校）。 通过将这6个机构的数据结合到患有NEC的婴儿的数据，可以进行更有意义的分析。 坏死性小肠结肠炎是一种严重的肠道疾病，发生在早产和低出生体重的婴儿中。 NEC在1060年代首次描述，现在是新生婴儿中最常见的手术紧急情况。 据报道，NEC的发病率从新生儿重症监护病房（NICU）入院的1％到5％，每1000例活产1至3例。 根据国家健康统计和多中心试验中心的数据分析，美国每年约有10,000例NEC案例。 这每年大约导致2500人死亡。 NEC的发生率与早产程度密切相关。 正是这些非常低的出生体重婴儿向医生带来了最大的临床挑战。 由于对NEC的成功治疗通常会导致孩子能够过上健康且充分生产的生活，因此，改善护理可以在挽救生命的年数方面产生巨大的影响。 NEC的临床表现范围从进食不耐症到心血管塌陷的严重败血症。 不存在对NEC的确切治疗。 大多数病例对以鼻胃减压，液体复苏，广谱抗生素和其他支持措施的方式响应口服喂养。 严重的NEC会导致肠坏死和穿孔。 当这些情况发生时，需要手术干预。 一旦对NEC进行了诊断，实践标准是进行肠休息，胃减压和广泛的抗生素。 许多患者对这种治疗的反应很好，并且没有进一步的干预措施恢复。 其他人会恶化并发展需要紧急手术的肠坏死或穿孔。 几乎没有可用的证据表明哪些因素可能有助于预测哪些婴儿最有可能恶化。 迄今为止，尚无大型前瞻性研究跟踪被诊断为NEC并确定其课程的婴儿。 识别恶化的危险因素可以使更深入的疗法专注于最有可能受益的疗法。 此外，此类数据可以允许对不高风险的人更快地回到肠内喂养和路由新生儿护理。