An interventional study of Phototherapy in Hyperbilirubinemia, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 35 Weeks and older. Per ClinicalTrials.gov, last updated 2012-12-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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.
135 studies on the registry are indexed under Hyperbilirubinemia; 18 are open to participants now.
This study's enrollment of 44 is below the median of 84 across 80 interventional studies indexed under Hyperbilirubinemia.
Browse Hyperbilirubinemia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LEDDYBLOO® phototherapy device equipped with 20 at 30 blue and white LEDs
Device: Phototherapy
Double BILITRON® phototherapy corresponding to two small ramps associated together each one equipped of 5 blue LEDS
Device: Phototherapy
Future phototherapy device equipped with 8 fluorescent tubes
Device: Phototherapy
Phototherapy devices of ramp type placed over the incubator to treat with light in the 420-490nm range one face of the naked baby suffering jaundice.
Bilirubinemia
Time frame: 24 hours
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
This study is terminated, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris