Zhang Emily, Wu Tzong-Jin, Hudak Mark L, Yan Ke, Teng Ru-Jeng
College of Human Ecology, Cornell University, Ithaca, NY, United States.
Department of Pediatrics, Division of Neonatology, Medical College of Wisconsin, Wauwatosa, WI, United States.
Front Pediatr. 2024 Dec 11;12:1446524. doi: 10.3389/fped.2024.1446524. eCollection 2024.
The gold standard for assessing neonatal jaundice (NJ) is the serum total serum bilirubin (TSB) level by the diazo method. A transcutaneous bilirubinometer (TCB) provides a convenient, noninvasive readout within minutes. The reliability of TCB as the diagnostic tool and the proper site for TCB measurement remains unsettled.
This study aimed to (1) evaluate the reliability of TCB in the NJ outpatient management and (2) identify a better site to obtain TCB readings.
This retrospective study examines data collected prospectively over 15 months at a level III facility. Parents were advised to bring their neonates back to our nursery if neonates were judged to be at risk for NJ or poor weight gain, and a follow-up with the primary practitioner was not available. Those who had received phototherapy or sustained forehead bruising were excluded from the analysis. Blood was collected immediately after TCB readings for TSB measurement using the di-azo method. The primary endpoint was admission for treatment according to the AAP 2004 guidelines. A mixed-effects model was used to assess the correlation of forehead TCB (TCB-) or sternal TCB (TCB-) with TSB by adjusting for age at measurement (hours), gestational age (GA), sex, and race. Repeated Measure Receiver Operator Characteristic (ROC) curves were constructed for TCB readings against the hospital admission, and the cutoffs for each method were selected to balance the sensitivity and specificity.
There were 500 visits for 350 neonates, including 136 females, 114 white, 134 black, 71 Hispanic, and 30 Asian. The mean GA was 38.5 weeks [standard deviation (SD) = 1.6], and the mean body weight (BW) was 3,238 g (SD = 506). Forty-five (12.9%) neonates were admitted for phototherapy or blood exchange transfusion according to the TSB levels. Only 43 admitted neonates had all three measurements. Assuming TCB has the same reading as TSB, 30 out of 43 (69.8%) and 20 out of 43 (46.5%) neonates would be sent home if only TCB- and TCB- were used, respectively. TCB has a trend of underestimating the necessity of hospitalization compared to TCB ( = 0.092 by McNemar test). After adjusting for age of measurement, GA, sex, and race, both TCB- and TCB- readings positively correlated with TSB ( < 0.0001). Using repeated measure ROC, with hospital admission for treatment as the primary outcome, the area under the curve (AUC) for TCB- was 0.79 (95% CI: 0.71-0.86), and AUC for TCB- was 0.86 (95% CI: 0.81-0.92). A cutoff of 14.3 for TCB- gave a sensitivity of 81% and a specificity of 78%. A cutoff of 12.6 for TCB- gave a sensitivity of 80% and a specificity of 65%.
TCB measurements can discriminate well in predicting admission for NJ treatment in our nursery but tend to underestimate the severity. The sternum is a better site for TCB measurements. We must point out that more than 40% of neonates who should be admitted for NJ management would be sent home if TSB were not obtained simultaneously. We recommend adjusting TCB readings according to unit-based calibration before clinical implementation.
评估新生儿黄疸(NJ)的金标准是采用重氮法测定血清总胆红素(TSB)水平。经皮胆红素测定仪(TCB)可在数分钟内提供便捷、无创的读数。TCB作为诊断工具的可靠性以及TCB测量的合适部位仍未确定。
本研究旨在(1)评估TCB在NJ门诊管理中的可靠性,以及(2)确定获取TCB读数的更佳部位。
这项回顾性研究分析了在一家三级医疗机构前瞻性收集的15个月的数据。如果新生儿被判定有NJ风险或体重增加不佳且无法与初级医生进行随访,建议家长将新生儿带回我们的新生儿护理室。接受过光疗或前额持续淤青的新生儿被排除在分析之外。在进行TCB读数后立即采集血液,采用重氮法测量TSB。主要终点是根据美国儿科学会2004年指南入院治疗。使用混合效应模型,通过调整测量时的年龄(小时)、胎龄(GA)、性别和种族,评估前额TCB(TCB-)或胸骨TCB(TCB-)与TSB的相关性。针对TCB读数与住院情况构建重复测量受试者操作特征(ROC)曲线,并选择每种方法的临界值以平衡敏感性和特异性。
350名新生儿共就诊500次,其中女性136名,白人114名,黑人134名,西班牙裔71名,亚洲人30名。平均GA为38.5周[标准差(SD)=1.6],平均体重(BW)为3238 g(SD=506)。根据TSB水平,45名(12.9%)新生儿因光疗或换血输血入院。仅43名入院新生儿进行了全部三项测量。假设TCB读数与TSB相同,若仅使用TCB-和TCB-,43名新生儿中分别有30名(69.8%)和20名(46.5%)会被送回家。与TCB相比,TCB有低估住院必要性的趋势(McNemar检验P=0.092)。在调整测量年龄、GA、性别和种族后,TCB-和TCB-读数均与TSB呈正相关(P<0.0001)。以住院治疗作为主要结局,采用重复测量ROC分析,TCB-的曲线下面积(AUC)为0.79(95%CI:0.71-0.86),TCB-的AUC为0.86(95%CI:0.81-0.92)。TCB-的临界值为14.3时,敏感性为81%,特异性为78%。TCB-的临界值为12.6时,敏感性为80%,特异性为65%。
在我们的新生儿护理室中,TCB测量在预测NJ治疗入院方面能很好地进行区分,但往往会低估严重程度。胸骨是进行TCB测量的更佳部位。我们必须指出,如果不同时测量TSB,超过40%应因NJ管理入院的新生儿会被送回家。我们建议在临床应用前根据单位校准调整TCB读数。