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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of related adverse events (Safety)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of related adverse events (Safety)
时间窗: at the end of phototherapy exposure (H4)
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
次要结局
- Transcutaneous bilirubin rate(Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours))
- EDIN (Newborn Pain and Discomfort Scale)(Baseline (H0) and 2 hours after the end of phototherapy (H4+2 hours))
- Perceptions of parents with the use of device(2 hours after the end of phototherapy (H4+2 hours))
- Perceptions of the health team with the use of the device(2 hours after the end of phototherapy (H4+2 hours))
- Blood bilirubin rate(Baseline and 2 hours after the end of phototherapy (H4+2 hours))