远程黄疸监测系统在新生儿高胆红素血症居家筛查中的临床转化可行性研究

孙小凡, 郑意, 苏爱玲, 韩树萍, 董小玥

中国当代儿科杂志 ›› 2025, Vol. 27 ›› Issue (9) : 1057-1061.

PDF(795 KB)
HTML
PDF(795 KB)
HTML
中国当代儿科杂志 ›› 2025, Vol. 27 ›› Issue (9) : 1057-1061. DOI: 10.7499/j.issn.1008-8830.2503110
论著·临床研究

远程黄疸监测系统在新生儿高胆红素血症居家筛查中的临床转化可行性研究

作者信息 +

Feasibility study on the clinical translation of a remote jaundice monitoring system for home-based screening of neonatal hyperbilirubinemia

Author information +
文章历史 +

摘要

目的 评估远程黄疸监测系统在新生儿高胆红素血症居家筛查中的临床应用价值及转化潜力。 方法 采用前瞻性自身配对研究设计,纳入2023年3—10月南京医科大学附属妇产医院538例胎龄≥35周、体重≥2 000 g、日龄≤14 d的新生儿。基于“中国新生儿小时经皮胆红素百分位曲线图”制订4种不同预测指标的筛查方案,评估系统效能,分析远程黄疸监测系统在真实家庭环境中使用的可行性。 结果 538对经皮胆红素与血清总胆红素配对值显示,两者显著相关(r=0.85,P<0.001),95.0%(511/538)的样本位于95%一致性界限内。以经皮胆红素值≥第95百分位数为预测指标,灵敏度达100%,特异度为46.2%,受试者操作特征曲线下面积为0.731(95%CI:0.682~0.780),可减少41.4%(221/538)非必要就诊。 结论 该系统整合QBH-801经皮黄疸仪、智能预警及远程指导服务,构建“医院-家庭”闭环管理模式,具备高安全性与可行性,临床转化价值显著。

Abstract

Objective To evaluate the clinical utility and translational potential of a remote jaundice monitoring system for home-based screening of neonatal hyperbilirubinemia. Methods A prospective self-controlled study was conducted, enrolling 538 newborns with gestational age ≥35 weeks, birth weight ≥2 000 g, and postnatal age ≤14 days at the Women's Hospital of Nanjing Medical University from March to October 2023. Four screening protocols with different predictive indicators were developed based on the Chinese Neonatal Transcutaneous Hourly Bilirubin Nomogram. The effectiveness of the system was evaluated, and the feasibility of using the remote jaundice monitoring system in actual home settings was analyzed. Results A total of 538 paired transcutaneous bilirubin (TcB) and total serum bilirubin (TSB) measurements showed a strong correlation (r=0.85, P<0.001), with 95.0% (511/538) of samples within the 95% limits of agreement. Using TcB ≥ the 95th percentile as the predictive indicator, the system achieved 100% sensitivity, 46.2% specificity, and an area under the receiver operating characteristic curve of 0.731 (95%CI: 0.682-0.780). This approach could reduce unnecessary hospital visits by 41.4% (221/538). Conclusions The system integrates the QBH-801 transcutaneous bilirubinometer, intelligent early warning, and remote guidance services, establishing a closed-loop "hospital-to-home" management model. It demonstrates high safety and feasibility, with significant clinical translational value.

关键词

新生儿高胆红素血症 / 经皮胆红素 / 居家筛查 / 新生儿

Key words

Neonatal hyperbilirubinemia / Transcutaneous bilirubin / Home screening / Newborn

引用本文

导出引用
孙小凡, 郑意, 苏爱玲, . 远程黄疸监测系统在新生儿高胆红素血症居家筛查中的临床转化可行性研究[J]. 中国当代儿科杂志. 2025, 27(9): 1057-1061 https://doi.org/10.7499/j.issn.1008-8830.2503110
Xiao-Fan SUN, Yi ZHENG, Ai-Ling SU, et al. Feasibility study on the clinical translation of a remote jaundice monitoring system for home-based screening of neonatal hyperbilirubinemia[J]. Chinese Journal of Contemporary Pediatrics. 2025, 27(9): 1057-1061 https://doi.org/10.7499/j.issn.1008-8830.2503110

参考文献

[1]
中华医学会儿科学分会新生儿学组, 《中华儿科杂志》编辑委员会. 新生儿高胆红素血症诊断和治疗专家共识[J]. 中华儿科杂志, 2014, 52(10): 745-748. PMCID: PMC7351698. DOI: 10.3760/cma.j.issn.0578-1310.2014.10.006 .
[2]
中华医学会儿科学分会新生儿学组, 中华儿科杂志编辑委员会. 新生儿高胆红素血症诊治指南(2025)[J]. 中华儿科杂志, 2025, 63(4): 338-350. DOI: 10.3760/cma.j.cn112140-20241231-00944 .
[3]
Kemper AR, Newman TB, Slaughter JL, et al. Clinical practice guideline revision: management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation[J]. Pediatrics, 2022, 150(3): e2022058859. DOI: 10.1542/peds.2022-058859 .
[4]
Amos RC, Jacob H, Leith W. Jaundice in newborn babies under 28 days: nice guideline 2016 (CG98)[J]. Arch Dis Child Educ Pract Ed, 2017, 102(4): 207-209. DOI: 10.1136/archdischild-2016-311556 .
[5]
Cortey A, Renesme L, Raignoux J, et al. Management of jaundice in the newborn≥35 GW: from screening to follow-up after discharge. Guidelines for clinical practice[J]. Arch Pediatr, 2017, 24(2): 192-203. DOI: 10.1016/j.arcped.2016.11.011 .
[6]
新生儿高胆红素血症临床研究协作组. 新生儿小时经皮胆红素百分位曲线图预测高胆红素血症价值的多中心临床研究[J]. 中华儿科杂志, 2015, 53(11): 830-834. DOI: 10.3760/cma.j.issn.0578-1310.2015.11.006 .
[7]
Lain SJ, Roberts CL, Bowen JR, et al. Early discharge of infants and risk of readmission for jaundice[J]. Pediatrics, 2015, 135(2): 314-321. DOI: 10.1542/peds.2014-2388 .
[8]
Battersby C, Michaelides S, Upton M, et al. Term admissions to neonatal units in England: a role for transitional care? A retrospective cohort study[J]. BMJ Open, 2017, 7(5): e016050. PMCID: PMC5726072. DOI: 10.1136/bmjopen-2017-016050 .
[9]
王增芹, 高艳, 董小玥, 等. 产科出院后因严重高胆红素血症住院新生儿入院前随访情况及随访依从性影响因素的多中心调查[J]. 中国当代儿科杂志, 2022, 24(6): 669-674. PMCID: PMC9250395. DOI: 10.7499/j.issn.1008-8830.2112113 .
[10]
Dong XY, Wei QF, Li ZK, et al. Causes of severe neonatal hyperbilirubinemia: a multicenter study of three regions in China[J]. World J Pediatr, 2021, 17(3): 290-297. DOI: 10.1007/s12519-021-00422-3 .
[11]
肖万祥, 杨婷, 张炼. 新生儿高胆红素血症再入院的现状和危险因素分析[J]. 中国当代儿科杂志, 2020, 22(9): 948-952. PMCID: PMC7499455. DOI: 10.7499/j.issn.1008-8830.2005003 .
[12]
容志惠, 罗芳, 马丽亚, 等. 基于智能手机应用软件拍照监测对新生儿高胆红素血症随访的意义[J]. 中华儿科杂志, 2016, 54(8): 597-600. DOI: 10.3760/cma.J.issn.0578-1310.2016.08.008 .
[13]
薛国昌, 张华丽, 丁学星, 等. 黄疸比色卡对新生儿高胆红素血症诊断效能的多中心评估[J]. 中华儿科杂志, 2024, 62(6): 535-541. DOI: 10.3760/cma.j.cn112140-20231106-00348 .
[14]
Kemper AR, Newman TB, Slaughter JL, et al. Clinical practice guideline revision: management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation[J]. Pediatrics, 2022, 150(3): e2022058859. DOI: 10.1542/peds.2022-058859 .
[15]
Taylor JA, Burgos AE, Flaherman V, et al. Discrepancies between transcutaneous and serum bilirubin measurements[J]. Pediatrics, 2015, 135(2): 224-231. PMCID: PMC4306797. DOI: 10.1542/peds.2014-1919 .
[16]
Han S, Yu Z, Liu L, et al. A model for predicting significant hyperbilirubinemia in neonates from China[J]. Pediatrics, 2015, 136(4): e896-e905. DOI: 10.1542/peds.2014-4058 .
[17]
Laupacis A, Sekar N, Stiell IG. Clinical prediction rules. A review and suggested modifications of methodological standards[J]. JAMA, 1997, 277(6): 488-494.
[18]
Maisels MJ, Bhutani VK, Bogen D, et al. Hyperbilirubinemia in the newborn infant > or =35 weeks' gestation: an update with clarifications[J]. Pediatrics, 2009, 124(4): 1193-1198. DOI: 10.1542/peds.2009-0329 .
[19]
Ebbesen F, Rasmussen LM, Wimberley PD. A new transcutaneous bilirubinometer, BiliCheck, used in the neonatal intensive care unit and the maternity ward[J]. Acta Paediatr, 2002, 91(2): 203-211. DOI: 10.1080/080352502317285225 .
[20]
Taylor JA, Burgos AE, Flaherman V, et al. Utility of decision rules for transcutaneous bilirubin measurements[J]. Pediatrics, 2016, 137(5): e20153032. PMCID: PMC4845868. DOI: 10.1542/peds.2015-3032 .

脚注

所有作者声明无利益冲突。

基金

江苏省医学会医学科研专项资金项目(SYH-32034-0072)
南京医科大学科技发展基金(NMUB20220113)

编委: 王颖

版权

版权所有 © 2023中国当代儿科杂志
PDF(795 KB)
HTML

Accesses

Citation

Detail

段落导航
相关文章

/