Department of Pediatrics, School of Medicine, Emory University, Atlanta, Georgia.
Children's Healthcare of Atlanta, Atlanta, Georgia; and.
Pediatrics. 2018 May;141(5). doi: 10.1542/peds.2017-4065.
: media-1vid110.1542/5727212367001PEDS-VA_2017-4065 OBJECTIVES: Determine the performance of the American Academy of Pediatrics (AAP) critical congenital heart disease (CCHD) newborn screening algorithm and the impact of an alternative algorithm.
Screening was performed on term infants without a known CCHD diagnosis at or near 24 hours of age at a tertiary birth hospital by using the AAP algorithm from 2013 to 2016. Retrospective review from the birth hospital and the area's sole pediatric cardiac center identified true- and false-positives and true- and false-negatives. A simulation study modeled the results of a modified screening algorithm with a single repeat pulse oximetry test instead of 2.
Screening results were collected on 77 148 newborns . By using the current AAP algorithm, 77 114 (99.96%) infants passed screening, 18 infants failed for an initial saturation of <90%, and 16 failed after not attaining a passing pulse oximetry level after 3 tests. There was 1 true-positive (total anomalous pulmonary venous return), 33 false-positives, and 6 false-negatives, yielding an overall specificity of 99.96%, a sensitivity of 14.3%, and a false-positive rate of 0.043%. Among false-positives, 10 (31.3%) had significant non-CCHD disease. Simulating the modified algorithm, sensitivity remained at 14.3%, and the false-positive rate increased to 0.054%.
Although CCHD screening in a tertiary care birth hospital may not detect many new cases of CCHD, it can detect other important diseases in newborns. Modifying the screening algorithm to 1 repeat pulse oximetry test instead of 2 may detect additional infants with significant disease without a substantial increase in the false-positive rate.
确定美国儿科学会(AAP)的先天性心脏病(CCHD)新生儿筛查算法的性能,以及替代算法的影响。
在一家三级分娩医院,对无已知 CCHD 诊断的足月婴儿在出生后 24 小时内或接近 24 小时进行 AAP 算法筛查。从出生医院和该地区唯一的儿科心脏中心进行回顾性审查,确定真阳性、假阳性、真阴性和假阴性。一项模拟研究对修改后的筛查算法进行了建模,该算法用单次重复脉搏血氧仪测试代替了 2 次测试。
共收集了 77148 例新生儿的筛查结果。使用现行的 AAP 算法,77114 例(99.96%)婴儿通过筛查,18 例婴儿初始饱和度<90%而失败,16 例婴儿在进行 3 次测试后未达到通过脉搏血氧仪水平而失败。有 1 例真阳性(完全性肺静脉异位引流),33 例假阳性和 6 例假阴性,总体特异性为 99.96%,敏感性为 14.3%,假阳性率为 0.043%。假阳性中有 10 例(31.3%)有重要的非 CCHD 疾病。模拟修改后的算法,敏感性仍为 14.3%,假阳性率增加至 0.054%。
尽管在三级护理分娩医院进行 CCHD 筛查可能无法发现许多新的 CCHD 病例,但它可以发现新生儿的其他重要疾病。将筛查算法修改为 1 次脉搏血氧仪测试,而不是 2 次,可能会在不显著增加假阳性率的情况下,发现更多患有严重疾病的婴儿。