Paradise J L
Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, PA, USA.
Pediatr Infect Dis J. 1998 Nov;17(11):1076-83; discussion 1099-100. doi: 10.1097/00006454-199811000-00038.
Persistent middle ear effusion in infancy and early childhood has been blamed for impairments of speech, language, cognition and psychosocial development later in life. Whether that blame is justified remains unresolved and a matter of controversy, because studies of the relationships involved have been limited and often contradictory and because none was designed so as to address the issue of causality. At issue in particular is the common practice of subjecting infants and young children with persistent otitis media with effusion (OME) to tympanostomy tube placement specifically to reduce the risk of developmental impairment. Currently children younger than age 3 years undergo an estimated 313000 tympanostomy tube placement operations per year, at a cost of about $750 million. If a causal association between early life OME and later developmental impairment were to be established, answers would also be needed to the questions whether the adverse effects of OME are linear or threshold, whether they are permanent or transient and whether they are preventable by timely tube placement. A prospective study designed to address all of these questions is currently under way at Children's Hospital of Pittsburgh. The study involves enrolling a large, demographically diverse sample of normal infants before 2 months of age; monitoring them for the presence or absence of otitis media throughout the first 3 years of life; identifying those in whom OME has persisted for specified minimum periods; randomly assigning those subjects either to prompt tube placement or to delayed tube placement if OME persists; and administering a battery of standardized developmental tests to those subjects and to a sample of the others at ages 3, 4 and 6 years. Details of the study design and procedures are described in this report.
婴幼儿期持续性中耳积液一直被认为是导致日后言语、语言、认知和心理社会发育受损的原因。这种指责是否合理仍未得到解决，且存在争议，因为相关关系的研究有限，且常常相互矛盾，而且没有一项研究是为解决因果关系问题而设计的。特别有争议的是，对于患有持续性中耳积液（OME）的婴幼儿，通常会进行鼓膜置管手术，专门以降低发育受损的风险。目前，估计每年有31.3万名3岁以下儿童接受鼓膜置管手术，费用约为7.5亿美元。如果要确定早期OME与后期发育受损之间存在因果关联，还需要回答以下问题：OME的不良影响是呈线性还是有阈值，是永久性的还是短暂的，以及是否可以通过及时置管来预防。匹兹堡儿童医院目前正在进行一项前瞻性研究，旨在解决所有这些问题。该研究包括招募大量2个月龄前的正常婴儿，这些婴儿在人口统计学上具有多样性；在其生命的前3年监测他们是否患有中耳炎；确定OME持续了特定最短时间的婴儿；如果OME持续存在，将这些婴儿随机分为立即置管组或延迟置管组；并在这些婴儿3岁、4岁和6岁时，对他们以及另一组样本进行一系列标准化发育测试。本报告将描述该研究设计和程序的详细情况。
