BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
NCT ID: NCT04365998
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2020-10-08
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BUBOLight® Device
BUBOLight® Device
1 session of phototherapy with BUBOLight® device during 4 hours.
Interventions
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BUBOLight® Device
1 session of phototherapy with BUBOLight® device during 4 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Days
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Thameur Rakza, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hop Jeanne de Flandre Chu Lille
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Role: primary
References
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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.
Other Identifiers
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2019-A01417-50
Identifier Type: OTHER
Identifier Source: secondary_id
2018_68
Identifier Type: -
Identifier Source: org_study_id