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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Neonatal Jaundice Device: BUBOLight® Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: BUBOLight® Device Device: BUBOLight® Device
1 session of phototherapy with BUBOLight® device during 4 hours.
Other Name: Phototherapy device with light emitting fabrics.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365998


Contacts
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Contact: Thameur Rakza, MD 03 20 44 63 87 ext +33 thameur.rakza@chru-lille.fr
Contact: Serge Mordon, PhD serge.mordon@inserm.fr

Sponsors and Collaborators
University Hospital, Lille
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Thameur Rakza, MD University Hospital, Lille
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04365998    
Other Study ID Numbers: 2018_68
2020- ( Other Identifier: ID-RCB number,ANSM )
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
jaundice
phototherapy
medical device
newborn
Additional relevant MeSH terms:
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Jaundice, Neonatal
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases