Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04365998

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

Up to 30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location status: Recruiting

Location contact

CONTACT

0320445962

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BUBOLight® Device

Device

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

Other names: Phototherapy device with light emitting fabrics.

Primary outcomes

  1. Number of related adverse events (Safety)

    Time frame: at the begin of phototherapy (baseline, H0)

    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

  2. Number of related adverse events (Safety)

    Time frame: at 2 hours after the beginning of phototherapy (H2)

    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

  3. Number of related adverse events (Safety)

    Time frame: at the end of phototherapy exposure (H4)

    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

Secondary outcomes

  1. Blood bilirubin rate

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

    Bilirubin lowering rate

  2. Transcutaneous bilirubin rate

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

    Bilirubin lowering rate

  3. EDIN (Newborn Pain and Discomfort Scale)

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

    Variation of the EDIN score between the beginning and 2 hours after phototherapy Minimum value = 0 and maximum value = 15. Above 5 pain is probable, below 5 pain is more likely to be discomfort than pain.

  4. Perceptions of parents with the use of device

    Time frame: 2 hours after the end of phototherapy (H4+2 hours)

    Validated survey at the end of treatment (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)

  5. Perceptions of the health team with the use of the device

    Time frame: 2 hours after the end of phototherapy (H4+2 hours)

    Validated survey at the end of treatment (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)

Study contacts

Contact information is provided by the study sponsor or research team.

Serge Mordon, PhD

CONTACT

[email protected]

Thameur Rakza, MD

CONTACT

[email protected]

03 20 44 63 87 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

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

Registry information

Official study 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

Acronym: BUBO

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.