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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
1 session of phototherapy with BUBOLight® device during 4 hours.
Hop Jeanne de Flandre Chu Lille
Lille, France
RECRUITINGNumber 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)
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