Clinical trial NCT04365998: BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Jaundice
Keywords: jaundice
phototherapy
medical device
newborn
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-04-28
Enrollment: 15
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Number of related adverse events (Safety)
timeFrame: at the begin of phototherapy (baseline, H0)
measure: Number of related adverse events (Safety)
timeFrame: at 2 hours after the beginning of phototherapy (H2)
measure: Number of related adverse events (Safety)
timeFrame: at the end of phototherapy exposure (H4)
Secondary outcomes:
measure: Blood bilirubin rate
timeFrame: Baseline and 2 hours after the end of phototherapy (H4+2 hours)
measure: Transcutaneous bilirubin rate
timeFrame: Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
measure: EDIN (Newborn Pain and Discomfort Scale)
timeFrame: Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
measure: Perceptions of parents with the use of device
timeFrame: 2 hours after the end of phototherapy (H4+2 hours)
measure: Perceptions of the health team with the use of the device
timeFrame: 2 hours after the end of phototherapy (H4+2 hours)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Thameur Rakza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.