Evidence map›Paper›PMID 40488806›Full record

ArticleEuropean journal of pediatrics2025

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

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

Abstract read
In one paragraph

Article in European journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jessie SpaanDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC Sophia Children's Hospital, University Medical Centre Rotterdam, Rotterdam, MC, Netherlands. j.spaan.1@erasmusmc.nl.ORCID http://orcid.org/0009-0001-0275-6771
Jasper V BeenDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC Sophia Children's Hospital, University Medical Centre Rotterdam, Rotterdam, MC, Netherlands.
Yanera WalléDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC Sophia Children's Hospital, University Medical Centre Rotterdam, Rotterdam, MC, Netherlands.
Irwin K M ReissDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC Sophia Children's Hospital, University Medical Centre Rotterdam, Rotterdam, MC, Netherlands.
Josephine H L WagenaarDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC Sophia Children's Hospital, University Medical Centre Rotterdam, Rotterdam, MC, Netherlands.
Christian V HulzebosDivision of Neonatology, Department of Paediatrics, Beatrix Children's Hospital, University Medical Centre Groningen, Groningen, the Netherlands.
Berthe A M van der GeestDivision of Neonatology, Department of Neonatal and Paediatric Intensive Care, Erasmus MC Sophia Children's Hospital, University Medical Centre Rotterdam, Rotterdam, MC, Netherlands.

Funding

Health Holland Erasmus MC-TKI-LSH PPP EMCLSH23046
6 · The paper itself

Abstract

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.

conclusionThis 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.

Indexed as

Hyperbilirubinemia, NeonatalPhototherapyWearable Electronic DevicesBilirubinFemaleHumansInfant, NewbornMaleNetherlandsPilot ProjectsProspective StudiesTreatment OutcomeBilirubinHome careNeonatal jaundicePhototherapyWearable

Identifiers

PMID40488806
PMCPMC12148988

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.