Actively Recruiting

Phase Not Applicable
Age: 0 - 30Days
All Genders
ID04365998

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

Led by University Hospital, Lille · Updated on 2025-12-23

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Lille

Lead Sponsor

I

Institut National de la Santé Et de la Recherche Médicale, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 30Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hop Jeanne de Flandre Chu Lille

Lille, France, 59037

Actively Recruiting

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Research Team

T

Thameur Rakza, MD

S

Serge Mordon, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Phototherapy Using a Light-Emitting Fabric (BUBOLight) Device in the Treatment of Newborn Jaundice: Protocol for an Interventional Feasibility and Safety Study.

Fabienne Lecomte, Elise Thecua, Laurine Ziane...

https://pubmed.ncbi.nlm.nih.gov/34032584