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Recruiting NCT04365998

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

No phase Interventional Neonatal Jaundice

For patients and families

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BUBOLight® Device.
Who it may be relevant to
Registry conditions: Neonatal Jaundice. Basic parameters: up to 30 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device BUBOLight® Device
    1 session of phototherapy with BUBOLight® device during 4 hours.

Primary outcome measures

  • Number of related adverse events (Safety) [Time frame: at the begin of phototherapy (baseline, H0)]
  • Number of related adverse events (Safety) [Time frame: at 2 hours after the beginning of phototherapy (H2)]
  • Number of related adverse events (Safety) [Time frame: at the end of phototherapy exposure (H4)]
Secondary outcome measures (5)
  • Blood bilirubin rate [Time frame: Baseline and 2 hours after the end of phototherapy (H4+2 hours)]
  • Transcutaneous bilirubin rate [Time frame: Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)]
  • EDIN (Newborn Pain and Discomfort Scale) [Time frame: Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)]
  • Perceptions of parents with the use of device [Time frame: 2 hours after the end of phototherapy (H4+2 hours)]
  • Perceptions of the health team with the use of the device [Time frame: 2 hours after the end of phototherapy (H4+2 hours)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Hop Jeanne de Flandre Chu Lille — Lille

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. PMID 34032584

Identifiers

NCT: NCT04365998 · 2018_68 · 2019-A01417-50

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗