Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn (DELF)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01136577
First received: June 2, 2010
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Hyperbilirubinemia
Device: Phototherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Light-emitting Diodes (LED) Phototherapy Versus Fluorescent Lamps Phototherapy for Treatment of Hyperbilirubinemia in Term Newborn

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Bilirubinemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of bilirubinemia according to the device used [ Time Frame: 6, 12,24, 48, 72 hours ] [ Designated as safety issue: No ]
  • Hyperbilirubinemia rebound according to the device used [ Time Frame: 24 and 48 hours after discontinuation ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEDDYBLOO®
LEDDYBLOO® phototherapy device equipped with 20 at 30 blue and white LEDs
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.
Other Name: Phototherapy
Experimental: Double BILITRON®
Double BILITRON® phototherapy corresponding to two small ramps associated together each one equipped of 5 blue LEDS
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.
Other Name: Phototherapy
Experimental: Futura®
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.
Other Name: Phototherapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Weeks and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborns in the hospital SAINT ANTOINE maternity wards
  • Gestational age of 35w or more
  • Healthy (no hypoxemia, no hypotonia, no abnormalities of thermic regulation, no infection or dehydration)
  • No foeto-maternal incompatibility in rhesus or kell group
  • With bilirubin level at 48h of 220µmoles/l or more if born at 38W or more or of 200µmoles/l or more if born between 35 and 38 W
  • Parental information done and signed consent obtained
  • Parents affiliated to social security

Exclusion Criteria:

  • Conjugated bilirubin level at 25µmol/l or more
  • Total bilirubin level over 300µmol/l indicating "intensive phototherapy"
  • Baby treated by phototherapy in the days before inclusion
  • Severe haemolytic disease with anemia below 14g/land or hyperbilirubinemia before 48h of life), rhesus or kell incompatibility
  • Parents who could not understand the information or sign the consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136577

Locations
France
CNRHP, Saint Antoine Hospital
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Anne Cortey, Doctor APHP
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01136577     History of Changes
Other Study ID Numbers: P070604
Study First Received: June 2, 2010
Last Updated: December 10, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Jaundice
Hyperbilirubinemia
Phototherapy
term newborn
LED
Fluorescent lamps

Additional relevant MeSH terms:
Hyperbilirubinemia
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014