BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice (BUBO)

Use of "BUBOLight®" Device as an Innovative Phototherapy Device for the Treatment of Newborn's Jaundice. A Monocentric, Descriptive Pilot Study, for the Feasibility, Safety and Tolerance of the BUBOLight® Device

About 50% of full-term newborns and 80% of premature infants develop jaundice which is due to hyperbilirubinemia. In the majority of cases, jaundice disappears naturally without treatment within three weeks of birth, but the bilirubin level may remain too high, which can lead to a serious neurological disease: kernicterus. To avoid this, a therapeutic management must be instituted, and in some cases, one or more phototherapy sessions (PT) may be prescribed.

The aim of this trial is to evaluate the safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy BUBOLight® included two removable strips of luminous textile incorporating optical fibers.

10 newborns requiring phototherapy, will be illuminated during four hours in one session of PT Bilirubin levels is taken at the start of phototherapy H0 and Controls are made at H+6 hours.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Jaundice
• Intervention / Treatment: Device: BUBOLight® Device

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thameur Rakza, MD; Phone Number: +33 03 20 44 63 87; Email: thameur.rakza@chru-lille.fr
• Study Contact Backup: Name: Serge Mordon, PhD; Email: serge.mordon@inserm.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Jeanne de Flandre Chu Lille
    • Contact: Phone Number: 0320445962

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At time of birth, infant is > 35 weeks gestation
• Presence of jaundice confirmed by measurement of bilirubin (transcutaneous bilirubinometer)
• Total bilirubinemia rate requiring phototherapy according to National Institute for Health and Clinical Excellence.
• Weight ≥2.500kg
• Judged in good health by the investigator following the clinical examination and the medical data (absence of perinatal asphyxia, antibiotic treatment, respiratory disorders)
• Absence of fœto-maternal rhesus incompatibility or Kell

Exclusion Criteria:

• Newborn already treated with phototherapy
• Febrile state with body temperature > 37.8°C
• Total bilirubinaemia level is equal or excess 100 μmol / L of the indication of phototherapy.
• Patient whose jaundice is due to haemolysis, obstruction functional or anatomical.
• Minor relative
• Newborn requiring exchange transfusion
• Newborn with congenital erythropoietic porphyria or a family history of porphyria.
• Patient requiring treatment other than phototherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BUBOLight® Device	Device: BUBOLight® Device; 1 session of phototherapy with BUBOLight® device during 4 hours.; Other Names: Phototherapy device with light emitting fabrics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of related adverse events (Safety)	Safety is defined as the ability to tolerate 4 hours of phototherapy without - Hyperthermia greater than or equal to 38.5 °C; Hypothermia less than or equal to 36 °C; Desaturation in O2 lower than 90% for more than 15 seconds; Heart rate greater than 160 / min at calm or less than 80 / min for more than 15 seconds; Allergic contact reaction grade ≥3	at the begin of phototherapy (baseline, H0)
Number of related adverse events (Safety)	Safety is defined as the ability to tolerate 4 hours of phototherapy without - Hyperthermia greater than or equal to 38.5 °C; Hypothermia less than or equal to 36 °C; Desaturation in O2 lower than 90% for more than 15 seconds; Heart rate greater than 160 / min at calm or less than 80 / min for more than 15 seconds; Allergic contact reaction grade ≥3	at 2 hours after the beginning of phototherapy (H2)
Number of related adverse events (Safety)	Safety is defined as the ability to tolerate 4 hours of phototherapy without - Hyperthermia greater than or equal to 38.5 °C; Hypothermia less than or equal to 36 °C; Desaturation in O2 lower than 90% for more than 15 seconds; Heart rate greater than 160 / min at calm or less than 80 / min for more than 15 seconds; Allergic contact reaction grade ≥3	at the end of phototherapy exposure (H4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood bilirubin rate	Bilirubin lowering rate	Baseline and 2 hours after the end of phototherapy (H4+2 hours)
Transcutaneous bilirubin rate	Bilirubin lowering rate	Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
EDIN (Newborn Pain and Discomfort Scale)	Variation of the EDIN score between the beginning and 2 hours after phototherapy Minimum value = 0 and maximum value = 15. Above 5 pain is probable, below 5 pain is more likely to be discomfort than pain.	Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
Perceptions of parents with the use of device	Validated survey at the end of treatment (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)	2 hours after the end of phototherapy (H4+2 hours)
Perceptions of the health team with the use of the device	Validated survey at the end of treatment (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)	2 hours after the end of phototherapy (H4+2 hours)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Thameur Rakza, MD, University Hospital, Lille

Publications and helpful links

General Publications

• Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Vamour C, Mordon S, Rakza T. Phototherapy Using a Light-Emitting Fabric (BUBOLight) Device in the Treatment of Newborn Jaundice: Protocol for an Interventional Feasibility and Safety Study. JMIR Res Protoc. 2021 May 25;10(5):e24808. doi: 10.2196/24808.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: phototherapy; medical device; newborn; jaundice
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Skin Manifestations; Hyperbilirubinemia, Neonatal; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Jaundice, Neonatal; Jaundice
• Other Study ID Numbers: 2018_68; 2019-A01417-50 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No