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

NCT04365998 | Recruiting DMC

• 2 other identifiers: 2018_682019-A01417-50
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Jaundice

Keywords

jaundice; phototherapy; medical device; newborn

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Blood bilirubin rate

  Baseline and 2 hours after the end of phototherapy (H4+2 hours)

• Transcutaneous bilirubin rate

  Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)

• EDIN (Newborn Pain and Discomfort Scale)

  Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)

• Perceptions of parents with the use of device

  2 hours after the end of phototherapy (H4+2 hours)

• Perceptions of the health team with the use of the device

  2 hours after the end of phototherapy (H4+2 hours)

Study Arms (1)

BUBOLight® Device

EXPERIMENTAL

Device: BUBOLight® Device

Interventions

BUBOLight® Device DEVICE

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

Also known as: Phototherapy device with light emitting fabrics.

BUBOLight® Device

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

RECRUITING

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Jaundice, Neonatal; Jaundice

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Thameur Rakza, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thameur Rakza, MD

CONTACT

03 20 44 63 87; thameur.rakza@chru-lille.fr

Serge Mordon, PhD

CONTACT

serge.mordon@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 28, 2020
• Study Start: October 8, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)