Clinical Trial: Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Comparison of Light-emitting Diodes (LED) Phototherapy Versus Fluorescent Lamps Phototherapy for Treatment of Hyperbilirubinemia in Term Newborn
Brief Summary: Phototherapy is almost (beside exchange transfusion) the unique treatment for hyperbilirubinemia of the newborn. Its efficacy to decrease bilirubin level (because the light interacts with bilirubin at the skin level to transform it in water soluble products eliminated in urine and stools without liver metabolism) relies on the irradiance dispensed at the skin level by the device (in the 430-490nm range) and on the exposed surface of the baby. In the past years, technology of phototherapy devices moved from fluorescent lamps to LED, improving the amount of light energy emitted but on a smaller surface. The purpose of the study is to compare the efficacy of three ramps of phototherapy, one equipped with fluorescent tubes and two with LED (in a different technological settings) in the treatment of term (35 GW or more) healthy newborn suffering hyperbilirubinemia after 2days of life.
Detailed Summary: Term and healthy newborns on maternity wards in SAINT-ANTOINE hospital are checked everyday for jaundice with bilirubinometer JM-103®. If indicated (nomogram included in patient charts), a plasmatic bilirubin level is performed. If the baby is two days old or more with a bilirubin level indicating standard phototherapy (by opposition to intensive phototherapy), the parents are informed of the research protocol and after obtention of parental consent, the baby is included. The newborn is admitted in the neonatology unit and randomised in one of the three phototherapy devices group. Plasmatic bilirubin levels are checked at 6,12 and 24 and 48 hours of phototherapy. At 12 hours of phototherapy, a biological checking is performed to address the etiology of the jaundice. The next plasmatic bilirubin level is performed at 72h after inclusion. During phototherapy treatment the baby is continuously monitored. Phototherapy is stopped when bilirubin level is below 200µmol/l. If the bilirubin level is increasing under one of this ramps or does not decrease at H24, the baby will be immediately move on intensive phototherapy and participation at the research protocol interrupted. Twenty four hours after the end of phototherapy treatment, plasmatic bilirubin level is checked to confirm the end of jaundice and statement is made for jaundice origin. The total duration of participation of a baby at this study is 72 hours.
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Bilirubinemia [ Time Frame: 24 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evolution of bilirubinemia according to the device used [ Time Frame: 6, 12,24, 48, 72 hours ]
- Hyperbilirubinemia rebound according to the device used [ Time Frame: 24 and 48 hours after discontinuation ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: June 2, 2010
Date Started: January 2010
Date Completion:
Last Updated: December 10, 2012
Last Verified: December 2012
