Efficacy of Tympanostomy Tubes for Children with Recurrent Acute Otitis Media

 描述(由申请人提供)：鼓膜造瘘管置入术(TTP)治疗复发性急性中耳炎(RAOM)通常在3岁以下的儿童中进行；然而，迫切需要确定其风险/收益比。70%的儿童在 出生一年内至少有一次AOM发作；20%的儿童有rAOM。TTP预防rAOM的效果尚不清楚，推测是通过维持中耳通气性来实现的。TTP的益处必须与麻醉风险、手术并发症和后遗症以及费用进行权衡。因此，这项建议的目的是确定TTP在6-35个月儿童中的疗效，这是rAOM最麻烦的群体。中心假设是，在患有rAOM的儿童中，手术将在接下来的两年内被证明是有效的，但在受影响更严重的亚组中，因此风险更高的亚组中的好处可能比受影响较轻的亚组大得多，在后者中，好处可能不会超过风险。这项研究的理由是基于这样一种信念，即 在早期临床试验中发现的TTP的好处可能是招募了那些没有使用严格的标准诊断疾病和/或其发作的确定依赖于未记录的病史的儿童。主要目标是确定TTP在多大程度上降低患有rAOM的儿童在两年内的总复发率。在第三阶段随机临床试验中，6-35个月大的有rAOM风险的儿童将接受前瞻性跟踪，并迅速检查有新的呼吸道疾病，以准确记录AOM的发作。共有240名符合rAOM严格纳入标准的儿童将有资格在不同阶层(年龄和接触其他儿童)内进行随机分组，接受TTP或非手术治疗。将对儿童进行为期两年的跟踪调查；AOM的平均发作次数将被记录下来，并在不同组之间进行比较。第二个目标是确定TTP后耐药细菌在鼻咽部(NP)定植的变化。随机分组，每年3次，连续2年，取标本进行培养。将进行药敏试验和血清分型，并比较不同治疗组之间儿童定植耐药细菌的比例。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费用，并将其与每个儿童出现AOM症状、耳漏以及任何不良事件或并发症的天数相关联。这项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。拟议的研究结果将为临床医生和家长提供可靠的证据，说明与非手术治疗相比，TTP对患有不同严重程度的rAOM的儿童的总体影响，从而使关于儿童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.