Efficacy of Tympanostomy Tubes for Children with Recurrent Acute Otitis Media

 描述（由申请人提供）：鼓膜造口置管（TTP）治疗复发性急性中耳炎（rAOM）经常在3岁以下儿童中进行;然而，迫切需要确定其风险/受益比。百分之七十的孩子经历过 在生命的第一年至少发生一次AOM; 20%的儿童患有rAOM。TTP预防rAOM的有效性（假设通过维持中耳通气）尚不清楚。TTP的受益必须与麻醉风险、手术并发症和后遗症以及成本相平衡。因此，本提案的目的是确定TTP在6-35个月儿童中的疗效，这是rAOM最麻烦的一组。中心假设是，在rAOM儿童中，手术将在随后的2年内被证明是有效的，但在受影响更严重的亚组中，因此风险较高的亚组的获益可能远大于受影响不太严重的亚组，其中获益可能不超过风险。这项研究的基本原理是基于一种信念，即有限的性质， 在早期临床试验中发现的TTP的益处可能是招募了未使用严格标准诊断疾病和/或依赖于未记录病史确定发作的儿童的结果。主要目的是确定TTP在多大程度上降低了rAOM儿童2年内的总体复发率。在一项3期随机临床试验中，将对有rAOM风险的6-35个月的儿童进行前瞻性随访，并及时检查新发呼吸道疾病，以准确记录AOM发作。符合rAOM严格入选标准的共240名儿童将有资格在分层（年龄和暴露于其他儿童）内接受随机分组，接受TTP或非手术治疗。将对儿童进行2年随访;记录AOM的平均发作次数，并进行组间比较。次要目的是确定TTP后鼻咽（NP）耐药菌定植的变化。在随机化时和2年内每年3次采集NP标本并进行培养。将进行药敏试验和血清分型，并比较治疗组之间耐药菌定植儿童的比例。第三个目标是确定TTP的成本效益。我们将计算直接医疗和非医疗成本，并将其与每个儿童出现AOM症状、耳炎和任何不良事件或并发症的天数相关联。拟议的研究是创新的，因为我们将使用严格的诊断标准前瞻性地记录AOM发作，并通过耳内窥镜获得数字鼓膜图像，以提高观察的准确性。拟议研究的结果将为临床医生和家长提供可靠的证据，与不同严重程度的rAOM儿童的非手术治疗相比，TTP的总体影响，使有关儿童医疗保健的重要组成部分的循证决策成为可能。

 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.