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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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