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

Neonatal Jaundice Clinical Trial

— BUBO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365998
• Other study ID #: 2018_68
• Secondary ID: 2019-A01417-50
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: October 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Thameur Rakza, MD
• Phone: 03 20 44 63 87
• Email: thameur.rakza[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

Device:
• BUBOLight® Device
1 session of phototherapy with BUBOLight® device during 4 hours.

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Blood bilirubin rate	Bilirubin lowering rate	Baseline and 2 hours after the end of phototherapy (H4+2 hours)
Secondary	Transcutaneous bilirubin rate	Bilirubin lowering rate	Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours)
Secondary	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)
Secondary	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)
Secondary	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)