A Phase 4 interventional study of two sessions of 4 hours Phototherapy treatment in Neonatal Hyperbilirubinemia, sponsored by Association Pédiatrique des Groupes d'Acuueil et de Recherche. Status unknown at 2 sites in France. Open to participants aged 35 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2014-06-05.
Sponsored by Association Pédiatrique des Groupes d'Acuueil et de Recherche · Phase 4, Interventional, and Treatment
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 ® 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 ² for an average 3,6 mW / cm ².
93 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.
This study's planned enrollment of 80 is below the median of 94 across 59 interventional studies indexed under Hyperbilirubinemia, Neonatal.
Browse Hyperbilirubinemia, Neonatal studies →This is the only study on the registry with Association Pédiatrique des Groupes d'Acuueil et de Recherche as lead sponsor.
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Exclusion Criteria:
two sessions of 4 hours Phototherapy treatment
Device: two sessions of 4 hours Phototherapy treatment
two sessions of 4 hours Phototherapy treatment
Device: two sessions of 4 hours Phototherapy treatment
two sessions of 4 hours Phototherapy treatment
EDIN Scale
EDIN scale will be measured 3 times during phototherapy treatment (base line, at 1 hour and at 4 Hour)
Time frame: base line, 60minutes, 240minutes
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)
Time frame: base line, at 12 hour and at 24 hour
This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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