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.<Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="left" colname="c1" colnum="1" /> <colspec align="left" colname="c2" colnum="2" /> <tbody> <row> <entry nameend="c2" namest="c1"> 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. </entry> </row> </tbody> </tgroup> </Table>

First in-human pilot study of wearable phototherapy for neonatal hyperbilirubinaemia

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2025年6月9日

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Jessie Spaan,
Jasper V. Been,
Yanera Wallé,
Irwin K. M. Reiss,
Josephine H. L. Wagenaar,
Christian V. Hulzebos,
Berthe A. M. van der Geest

摘要

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.