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| Name | Class |
|---|---|
| Hopital Antoine Beclere | OTHER |
| Bicetre Hospital | OTHER |
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Jaundice occurs in most newborn infants. Most jaundice is benign, but because of the potential toxicity of bilirubin, newborn infants must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. Jaundice is a commonly observed, usually harmless condition in newborn infants during the first week after birth. However, in some babies the amount of bilirubin pigment can increase to dangerous levels and require treatment. Treatment of jaundice in newborn infants is done by placing them under phototherapy, a process of exposing their skin to light of a specific wavelength band. Fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. A light-emitting diode (LED) is a newer type of light source which is power efficient, has a longer life and is portable with low heat production. Several technologies and devices are developed around this LED and specially a compact system.
The purpose of this study is to evaluate efficacity of LED phototherapy by comparing with conventional phototherapy (non-LED) and satisfaction of the parents and the professional staff about comfort of this new technology. The newborn infant is placed in a sleeper with the device B' bloo Âź which maintains him in position (lap or dorsal) allowing to pass the blue light. This one is generated by the module LED and transmitted in the braid of optical fibers which takes place directly on the mattress of the cradle in which is placed the patient usually.
The device is endowed with an hour counter to schedule the time of treatment. The energy illumination varies between 3 and 4 mW / cm ÂČ for an average 3,6 mW / cm ÂČ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OBLOO device (MEDIPREMA) | Active Comparator | two sessions of 4 hours Phototherapy treatment |
|
| BBLOO Device (MEDIPREMA) | Experimental | two sessions of 4 hours Phototherapy treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| two sessions of 4 hours Phototherapy treatment | Device | two sessions of 4 hours Phototherapy treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| EDIN Scale | EDIN scale will be measured 3 times during phototherapy treatment (base line, at 1 hour and at 4 Hour) | base line, 60minutes, 240minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Blood Bilirubin level | blood bilirubin concentration will be measured 3 times during phototherapy treatment (base line, at 12 hour and at 24 Hour) | base line, at 12 hour and at 24 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| emmanuelle letamendia, MD | Contact | 0145374641 | emmanuelle.letamendia@abc.aphp.fr | |
| claire boithias, MD | Contact | 0145213205 | claire.boithias@bct.aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hopital Antoine BéclÚre | Recruiting | Clamart | 92140 | France |
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| Bicetre Hospital | Recruiting | Le Kremlin-BicĂȘtre | 94275 | France |
|
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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