Efficacy of Tympanostomy Tubes for Children with Recurrent Acute Otitis Media

鼓室置管术治疗儿童复发性急性中耳炎的疗效

基本信息

批准号：
9762077
负责人：
ALEJANDRO HOBERMAN
金额：
$ 91.89万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-07-14 至 2021-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9762077
关键词：
15 year old 3 year old Academy Acute Adverse effects Adverse event Affect Age American Anesthesia procedures Antibiotics Belief Child Child health care Childhood Cicatrix Clinical Trials Coupled Data Decision Making Development Diagnosis Diagnostic Dose Ear Eligibility Determination Enrollment Exposure to Goals Granulation Tissue Healthcare Image Life Medical Methodology Middle Ear Ventilation Nature Newborn Infant Operative Surgical Procedures Otitis Media Otorrhea Parents Pear Pediatrics Perforation Performance Phase Predisposition Procedures Prophylactic treatment Randomized Randomized Clinical Trials Recording of previous events Recurrence Research Resistance Resources Risk Serotyping Severities Specimen Subgroup Symptoms Testing Time Training Tube Tympanic membrane Tympanostomy Uncertainty United States United States Food and Drug Administration age group aged anesthesia complication antimicrobial bacterial resistance base care costs clinical practice cost cost effective cost effectiveness digital efficacy study evidence base evidence based guidelines experience follow-up high risk inclusion criteria innovation middle ear operation premature prevent prospective public health relevance respiratory risk benefit ratio treatment group trial comparing

项目摘要

DESCRIPTION (provided by applicant): Tympanostomy tube placement (TTP) for recurrent acute otitis media (rAOM) is frequently performed in children under 3 years of age; however, a critical need exists to establish its risk/benefit ratio. Seventy percent of children experience at least one episode of AOM during the first year of life; 20% of children have rAOM. The efficacy of TTP for preventing rAOM, assumedly by maintaining middle-ear ventilation, remains unclear. Benefits of TTP must be balanced against risks of anesthesia, complications and sequelae of surgery, and cost. Accordingly, the objective of this proposal is to determine the efficacy of TTP in children aged 6-35 months, the group in which rAOM is most troublesome. The central hypothesis is that in children with rAOM, the operation will prove effective over the ensuing 2 years overall, but the benefit in a more severely affected, and therefore higher-risk subgroup may be substantially greater than in a less severely affected subgroup, in whom benefits may not outweigh risks. The rationale for this research is based on a belief that the limited nature of the benefit of TTP found in earlier clinical trials may have been the result of enrolling children whose illnesses had not been diagnosed using stringent criteria and/or whose ascertainment of episodes had relied on undocumented histories. The primary objective is to determine the extent to which TTP reduces the overall rate of recurrences in children with rAOM over a 2-year period. In a phase 3 randomized, clinical trial, children aged 6-35 months who are at risk for rAOM will be followed prospectively and examined promptly with new respiratory illnesses to accurately document episodes of AOM. A total of 240 children who meet stringent inclusion criteria for rAOM will be eligible to undergo randomization within strata (age and exposure to other children) to receive TTP or nonsurgical management. Children will be followed for 2 years; the average number of episodes of AOM will be documented and compared between groups. The secondary objective is to determine changes following TTP in nasopharyngeal (NP) colonization with resistant bacteria. At the time of randomization and 3 times a year for 2 years, NP specimens will be obtained and cultured. Susceptibility testing and serotyping will be performed, and the proportions of children colonized with resistant bacteria compared between treatment groups. The tertiary objective is to determine cost-effectiveness of TTP. We will calculate both direct medical and nonmedical costs and correlate this with the number of days that each child has AOM symptoms, otorrhea, and any adverse events or complications. The proposed research is innovative, as we will document AOM episodes prospectively using stringent diagnostic criteria and obtain digital tympanic membrane images otoendoscopically to enhance accuracy of observations. Findings of the proposed study will provide clinicians and parents with dependable evidence concerning the overall effects of TTP compared with nonsurgical management in children with rAOM of varying degrees of severity, enabling evidence-based decisions regarding an important component of the children's healthcare.

描述（由应用提供）：针对复发性急性中耳炎（RAOM）的鼓膜造口术放置（TTP）经常在3岁以下的儿童中进行；但是，存在建立风险/利益比率的临界需求。百分之七十的孩子在在生命的第一年，至少有一集AOM； 20％的儿童患有RAOM。 TTP预防RAOM的效率据称是通过维持中耳通气，尚不清楚。 TTP的益处必须与麻醉，并发症和后遗症的风险和成本保持平衡。根据每个提案的目的，该提案的目的是确定TTP在6-35个月的儿童中的效率，这是RAOM最麻烦的群体。中心假设是，在RAOM的儿童中，该手术将在确保整体2年中有效，但是受到更严重影响的益处，因此高风险的亚组可能大大比受影响不太受影响的亚组大得多，其中福利可能不会超过风险。这项研究的理由是基于一种信念，即在较早的临床试验中发现的TTP的好处可能是招募儿童的结果，他们的疾病未被诊断出使用严格的标准和/或确定发作的确定性依赖于无证件的历史。主要目的是确定TTP在2年内降低RAOM儿童的总回报率的程度。在3阶段的随机临床试验中，有前瞻性的6-35个月儿童将受到RAOM风险的危险，并迅速检查新的呼吸道疾病，以准确记录AOM发作。总共符合RAOM的严格纳入标准的240名儿童将有资格在阶层（年龄和接触其他儿童）内进行随机性，以接受TTP或非手术管理。儿童将被追踪2年；将记录和比较组之间的平均AOM发作数量。次要目标是确定鼻咽（NP）与耐药细菌定植后TTP后的变化。在随机化时，每年3次，共2年，将获得和培养NP标本。将进行敏感性测试和血清，并在治疗组之间进行抗性细菌的儿童比例。三级目标是确定TTP的成本效益。我们将计算直接的医疗和非医疗费用，并将其与每个孩子具有AOM症状，耳视和任何不良事件或并发症的天数相关。拟议的研究具有创新性，因为我们将使用严格的诊断标准前瞻性地记录AOM发作，并在耳镜上获得数字鼓膜图像，以提高观察值的准确性。拟议研究的结果将为临床医生和父母提供有关TTP总体影响的可靠证据，而与非手术性管理相比，患有不同程度的严重程度的儿童，有助于有关儿童医疗保健重要组成部分的基于证据的决定。