BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
ConditionNeonatal Jaundice
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorUniversity Hospital, Lille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
BUBOLight® Device
Device1 session of phototherapy with BUBOLight® device during 4 hours.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: BUBOLight® DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
at the begin of phototherapy (baseline, H0)2
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
Time frame
at 2 hours after the beginning of phototherapy (H2)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
Time frame
at the end of phototherapy exposure (H4)Secondary outcomes
1
Blood bilirubin rate
Bilirubin lowering rate
Time frame
Baseline and 2 hours after the end of phototherapy (H4+2 hours)2
Transcutaneous bilirubin rate
Bilirubin lowering rate
Time frame
Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)3
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.
Time frame
Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)4
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)
Time frame
2 hours after the end of phototherapy (H4+2 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Source ClinicalTrials.gov