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

Primary Purpose

Neonatal Jaundice

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BUBOLight® Device
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Jaundice focused on measuring jaundice, phototherapy, medical device, newborn

Eligibility Criteria

undefined - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hop Jeanne de Flandre Chu LilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BUBOLight® Device

Arm Description

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Blood bilirubin rate
Bilirubin lowering rate
Transcutaneous bilirubin rate
Bilirubin lowering rate
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.
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)
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)

Full Information

First Posted
April 15, 2020
Last Updated
March 1, 2022
Sponsor
University Hospital, Lille
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04365998
Brief Title
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
Acronym
BUBO
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice
Keywords
jaundice, phototherapy, medical device, newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BUBOLight® Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
BUBOLight® Device
Other Intervention Name(s)
Phototherapy device with light emitting fabrics.
Intervention Description
1 session of phototherapy with BUBOLight® device during 4 hours.
Primary Outcome Measure Information:
Title
Number of related adverse events (Safety)
Description
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
Time Frame
at the begin of phototherapy (baseline, H0)
Title
Number of related adverse events (Safety)
Description
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
Time Frame
at 2 hours after the beginning of phototherapy (H2)
Title
Number of related adverse events (Safety)
Description
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
Time Frame
at the end of phototherapy exposure (H4)
Secondary Outcome Measure Information:
Title
Blood bilirubin rate
Description
Bilirubin lowering rate
Time Frame
Baseline and 2 hours after the end of phototherapy (H4+2 hours)
Title
Transcutaneous bilirubin rate
Description
Bilirubin lowering rate
Time Frame
Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
Title
EDIN (Newborn Pain and Discomfort Scale)
Description
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.
Time Frame
Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
Title
Perceptions of parents with the use of device
Description
Validated survey at the end of treatment (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
Time Frame
2 hours after the end of phototherapy (H4+2 hours)
Title
Perceptions of the health team with the use of the device
Description
Validated survey at the end of treatment (comfort, heat, humidity, ease of breastfeeding, proximity and possibility of contact with the baby)
Time Frame
2 hours after the end of phototherapy (H4+2 hours)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thameur Rakza, MD
Phone
03 20 44 63 87
Ext
+33
Email
thameur.rakza@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Serge Mordon, PhD
Email
serge.mordon@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thameur Rakza, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Jeanne de Flandre Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

Citations:
PubMed Identifier
34032584
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.
Results Reference
derived

Learn more about this trial

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

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