Ellison R C, Peckham G J, Lang P, Talner N S, Lerer T J, Lin L, Dooley K J, Nadas A S
Pediatrics. 1983 Mar;71(3):364-72.
As a first step in a multicenter, collaborative project to study the role of indomethacin in the management of patent ductus arteriosus in premature infants, a diagnostic scheme was developed, on an a priori basis, by a consensus of the participating neonatologists and pediatric cardiologists. The scheme, which utilizes clinical and noninvasive findings, was designed to detect infants with a "hemodynamically significant" patent ductus arteriosus (PDA). Among 1,689 infants with birth weight less than 1,750 g who were monitored during the first year of the study, 342 (20.2%) met the criteria for PDA. Rates were higher for smaller infants (42% with birth weight less than 1,000 g) than for larger infants (7% with birth weight 1,500 to 1,750 g). Although study protocol did not require a direct procedure to confirm the diagnosis of PDA, a marked decrease in the presence of most criteria was noted following surgical ligation of the ductus. Although the echocardiographic criterion (ratio of left atrium to aorta [LA/Ao] greater than or equal to 1.15) proved to have a low specificity for PDA, the data suggest that the overall scheme led to a very low rate of false-positive diagnosis. Following the application of the scheme for 1 year at 13 clinical centers, it has been shown to be a highly acceptable means of detecting infants with PDA.
作为一项多中心合作项目的第一步，该项目旨在研究吲哚美辛在早产儿动脉导管未闭管理中的作用，参与研究的新生儿科医生和儿科心脏病专家经共识预先制定了一种诊断方案。该方案利用临床和非侵入性检查结果，旨在检测出患有“血流动力学显著”动脉导管未闭（PDA）的婴儿。在研究的第一年中对1689名出生体重低于1750克的婴儿进行了监测，其中342名（20.2%）符合PDA标准。较小婴儿（出生体重低于1000克的婴儿中42%）的发病率高于较大婴儿（出生体重1500至1750克的婴儿中7%）。尽管研究方案并不要求通过直接检查程序来确诊PDA，但在对导管进行手术结扎后，大多数标准的出现率显著下降。尽管超声心动图标准（左心房与主动脉之比[LA/Ao]大于或等于1.15）对PDA的特异性较低，但数据表明总体方案导致假阳性诊断率非常低。在13个临床中心应用该方案1年后，已证明它是检测患有PDA婴儿的一种高度可接受的方法。
