An interventional study of BUBOLight® Device in Neonatal Jaundice, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 15 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: BUBOLight® Device
1 session of phototherapy with BUBOLight® device during 4 hours.
Also known as: Phototherapy device with light emitting fabrics.
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)
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)
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)
Blood bilirubin rate
Bilirubin lowering rate
Time frame: Baseline and 2 hours after the end of phototherapy (H4+2 hours)
Transcutaneous bilirubin rate
Bilirubin lowering rate
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 2 hours after the end of phototherapy (H4+2 hours)
Started Oct 2020 (actual). Primary completion is estimated for Dec 2026, 74 months after the start.
Of 35 non-industry interventional studies with no phase under Jaundice, Neonatal, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 74 months is above that.
Counting every sponsor, half of 45 studies reached it within 11 months; a quarter within 5 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
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