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（由申请人提供）：针对复发性急性中耳炎 (rAOM) 的鼓膜置管术 (TTP) 经常在 3 岁以下的儿童中进行；然而，迫切需要确定 70% 的儿童的风险/获益比。经验在出生后第一年至少发生过一次 AOM；20% 的儿童患有 rAOM。TTP（假定通过维持中耳通气）预防 rAOM 的功效仍不清楚。TTP 的益处必须与麻醉风险相平衡。因此，本提案的目的是确定 TTP 对 6-35 个月儿童的疗效，该组儿童中 rAOM 最为棘手。 rAOM，该操作将在接下来的两年内被证明是有效的，但受影响较严重、因此风险较高的亚组的收益可能远大于受影响较轻的亚组，后者的收益可能不会超过风险。这项研究的基础是这样的信念：早期临床试验中发现的 TTP 的益处可能是由于招募了未使用严格标准诊断疾病和/或其发作依赖于无证病史的儿童。主要目标是确定 TTP 的程度。总体上降低了 rAOM 儿童在 2 年内的复发率。在一项 3 期随机临床试验中，将对有 rAOM 风险的 6-35 个月儿童进行前瞻性随访，并及时进行新型呼吸道肺炎检查。准确记录 AOM 的发作情况。总共 240 名符合 rAOM 严格纳入标准的儿童将有资格在分层（年龄和与其他儿童接触）中进行随机分组，以接受 TTP 或非手术治疗。将记录 AOM 的平均发作次数，并在各组之间进行比较。次要目标是确定随机分组时鼻咽 (NP) 定植的变化以及每年 3 次。为期 2 年，将获取 NP 样本并进行药敏试验和血清分型，并比较治疗组之间耐药细菌定植的儿童比例，我们将计算两者的成本效益。直接医疗和非医疗费用，并将其与每个孩子出现 AOM 症状、耳漏和任何不良事件或并发症的天数联系起来。拟议的研究是创新的，因为我们将前瞻性地记录 AOM 发作。使用严格的诊断标准并通过耳内窥镜获取数字鼓膜图像，以提高观察的准确性，拟议研究的结果将为受青睐的家长提供有关 TTP 与非手术治疗对不同严重程度的儿童的总体效果的相关证据，就儿童医疗保健的一个重要组成部分做出基于证据的决策。