Neonatal JaundiceBUBONCT04365998
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
A study testing BUBOLight® Device in people with Neonatal Jaundice, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- BUBOLight® Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serge Mordon, PhD contact
France1 site, 1 recruiting
- Recruiting
Hop Jeanne de Flandre Chu Lille
Lille, 59037
0320445962
About this study
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
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
- Being tested
- BUBOLight® Device
- Keywords
- jaundice, phototherapy, medical device, newborn
- Medical subject headings
- Jaundice, Neonatal, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BUBOLight® DeviceDevice
Also called Phototherapy device with light emitting fabrics.
1 session of phototherapy with BUBOLight® device during 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| BUBOLight® Device | Experimental | Not described Receives: Device: BUBOLight® Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: at the end of phototherapy exposure (H4)
Secondary outcomes (5)
Blood bilirubin rate
Bilirubin lowering rate
Measured: Baseline and 2 hours after the end of phototherapy (H4+2 hours)
Transcutaneous bilirubin rate
Bilirubin lowering rate
Measured: Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
EDIN (Newborn Pain and Discomfort Scale)
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.
Measured: Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
Perceptions of parents with the use of device
Validated survey at the end of treatment (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
Measured: 2 hours after the end of phototherapy (H4+2 hours)
Perceptions of the health team with the use of the device
Validated survey at the end of treatment (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
Measured: 2 hours after the end of phototherapy (H4+2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start8 Oct 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thameur Rakza, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365998
- Sponsor's protocol ID
- 2018_68
- Other IDs
- 2019-A01417-50
- Acronym
- BUBO
- Status last verified
- Dec 2025
- First submitted
- 15 Apr 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34032584
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04365998
- Acronym / sponsor ID
- BUBO / 2018_68
- Conditions
- Neonatal Jaundice
- Keywords
- jaundice, phototherapy, medical device, newborn
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BUBOLight® Device | Experimental | Device: BUBOLight® Device |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BUBOLight® DeviceAlso: Phototherapy device with light emitting fabrics.1 session of phototherapy with BUBOLight® device during 4 hours. | Device | BUBOLight® Device |
Primary outcome
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
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
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
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 34032584Lecomte 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.
Related trials for Neonatal Jaundice
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serge Mordon, PhD contact
Thameur Rakza, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BUBOLight® Device in people with Neonatal Jaundice, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thameur Rakza, MD (03 20 44 63 87 ext. +33, thameur.rakza@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of related adverse events (Safety) (time frame: at the begin of phototherapy (baseline, H0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04365998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.