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

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ClinicalTrials.gov Identifier: NCT04365998
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : March 9, 2021
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE April 15, 2020
First Posted Date  ICMJE April 28, 2020
Last Update Posted Date March 9, 2021
Estimated Study Start Date  ICMJE June 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Blood bilirubin rate [ Time Frame: Baseline and 2 hours after the end of phototherapy (H4+2 hours) ]
    Bilirubin lowering rate
  • Transcutaneous bilirubin rate [ Time Frame: Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours) ]
    Bilirubin lowering rate
  • 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.
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neonatal Jaundice
Intervention  ICMJE Device: BUBOLight® Device
1 session of phototherapy with BUBOLight® device during 4 hours.
Other Name: Phototherapy device with light emitting fabrics.
Study Arms  ICMJE Experimental: BUBOLight® Device
Intervention: Device: BUBOLight® Device
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2020)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thameur Rakza, MD 03 20 44 63 87 ext +33 thameur.rakza@chru-lille.fr
Contact: Serge Mordon, PhD serge.mordon@inserm.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04365998
Other Study ID Numbers  ICMJE 2018_68
2020- ( Other Identifier: ID-RCB number,ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Thameur Rakza, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP