新生儿高胆红素血症可穿戴光疗的首次人体试点研究。
First in-human pilot study of wearable phototherapy for neonatal hyperbilirubinaemia.
作者信息
Spaan Jessie, Been Jasper V, Wallé Yanera, Reiss Irwin K M, Wagenaar Josephine H L, Hulzebos Christian V, van der Geest Berthe A M
机构信息
Division of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC Sophia Children's Hospital, University Medical Centre Rotterdam, Rotterdam, MC, Netherlands.
Department of Obstetrics and Gynaecology, Erasmus MC Sophia Children's Hospital, University Medical Centre Rotterdam, Rotterdam, the Netherlands.
出版信息
Eur J Pediatr. 2025 Jun 9;184(7):407. doi: 10.1007/s00431-025-06239-w.
UNLABELLED
This pilot study aimed to assess the effectiveness and safety of the first wearable phototherapy device in (near-)term neonates with unconjugated hyperbilirubinaemia. This prospective single-arm intervention pilot study was conducted in the Erasmus MC Sophia Children's Hospital maternity ward and the Primary Care Birth Centre Sophia in Rotterdam, the Netherlands. Twelve (near-)term neonates with hyperbilirubinaemia requiring treatment, according to the Dutch national hyperbilirubinaemia guideline, were treated with wearable phototherapy. Results were compared to a matched historical cohort of neonates treated with BiliSoft. Effective and safe treatment was defined by (1) the ability to discontinue phototherapy within 48 h after initiation and (2) no adverse events that necessitate switching to a conventional phototherapy device, as indicated by an independent expert. Twelve neonates were included, with a median gestational age of 38.5 weeks (IQR 37.9-39.2) and a median postnatal age of 77 h (IQR 58-87). In ten neonates (83%), phototherapy was successfully completed within 48 h, with a median phototherapy duration of 23 h (IQR 22.5-30.3) and a median TSB reduction rate of 1.8 µmol/L/h (IQR 2.3-1.1). These findings were similar in the control group. Two neonates were switched to conventional intensive phototherapy due to the ongoing rise of bilirubin levels despite wearable phototherapy treatment. No safety issues were recorded. Parents and healthcare providers reported positive experiences, highlighting benefits such as mobility and increased parental autonomy.
CONCLUSION
This pilot study provides data to indicate that wearable phototherapy is effective and safe in reducing bilirubin levels in the majority of (near-)term neonates with hyperbilirubinaemia.
WHAT IS KNOWN
• Home phototherapy for neonatal hyperbilirubinaemia is generally regarded as a safe and effective alternative to in-hospital phototherapy. • The current fibreoptic phototherapy devices have limitations that hinder their optimal use in the home setting.
WHAT IS NEW
• Wearable phototherapy is effective and safe in reducing bilirubin levels in the majority of (near-)term neonates with hyperbilirubinaemia.
未标注
本前瞻性单臂干预试验旨在评估首款可穿戴光疗设备对（近）足月未结合型高胆红素血症新生儿的有效性和安全性。该试验在荷兰鹿特丹伊拉斯姆斯医学中心索菲亚儿童医院产科病房和索菲亚初级保健分娩中心进行。根据荷兰国家高胆红素血症指南，12名需要治疗的（近）足月高胆红素血症新生儿接受了可穿戴光疗。将结果与一组匹配的接受BiliSoft治疗的历史新生儿队列进行比较。有效且安全的治疗定义为：（1）开始治疗后48小时内能够停止光疗；（2）如独立专家所示，无需要改用传统光疗设备的不良事件。纳入12名新生儿，中位胎龄为38.5周（四分位间距37.9 - 39.2），中位出生后年龄为77小时（四分位间距58 - 87）。10名新生儿（83%）在48小时内成功完成光疗，中位光疗时长为23小时（四分位间距22.5 - 30.3），中位总胆红素降低率为1.8µmol/L/小时（四分位间距2.3 - 1.1）。对照组的这些结果相似。2名新生儿尽管接受了可穿戴光疗，但由于胆红素水平持续上升而改用传统强化光疗。未记录到安全问题。家长和医护人员报告了积极的体验，强调了诸如活动便利性和家长自主性增加等益处。
结论
本试验研究提供的数据表明，可穿戴光疗对大多数（近）足月高胆红素血症新生儿降低胆红素水平是有效且安全的。
已知信息
• 新生儿高胆红素血症的家庭光疗通常被认为是院内光疗的一种安全有效的替代方法。• 当前的光纤光疗设备存在局限性，阻碍了它们在家庭环境中的最佳使用。
新发现
• 可穿戴光疗对大多数（近）足月高胆红素血症新生儿降低胆红素水平是有效且安全的。
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