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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01417-50 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUBOLight® Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BUBOLight® Device | Device | 1 session of phototherapy with BUBOLight® device during 4 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 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
| 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
| at the end of phototherapy exposure (H4) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood bilirubin rate | Bilirubin lowering rate | Baseline and 2 hours after the end of phototherapy (H4+2 hours) |
| Transcutaneous bilirubin rate | Bilirubin lowering rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thameur Rakza, MD | Contact | 03 20 44 63 87 | +33 | thameur.rakza@chru-lille.fr |
| Serge Mordon, PhD | Contact | serge.mordon@inserm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thameur Rakza, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Jeanne de Flandre Chu Lille | Recruiting | Lille | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34032584 | Result | Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Vamour C, Mordon S, Rakza T. Phototherapy Using a Light-Emitting Fabric (BUBOLight) Device in the Treatment of Newborn Jaundice: Protocol for an Interventional Feasibility and Safety Study. JMIR Res Protoc. 2021 May 25;10(5):e24808. doi: 10.2196/24808. |
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| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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| 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. | 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) | 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) | 2 hours after the end of phototherapy (H4+2 hours) |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |