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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neonatal Jaundice

Intervention / Treatment
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* Device: BUBOLight® Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUBOLight® Device<br> | Device: BUBOLight® Device<br>* 1 session of phototherapy with BUBOLight® device during 4 hours.<br>* Other names: Phototherapy device with light emitting fabrics.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | at the end of phototherapy exposure (H4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood bilirubin rate | Bilirubin lowering rate | Baseline and 2 hours after the end of phototherapy (H4+2 hours) | 
| Transcutaneous bilirubin rate | Bilirubin lowering rate | 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. | 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) | 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) | 2 hours after the end of phototherapy (H4+2 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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jaundice, phototherapy, medical device, newborn