Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn (DELF)
Primary Purpose
Hyperbilirubinemia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hyperbilirubinemia focused on measuring Jaundice, Hyperbilirubinemia, Phototherapy, term newborn, LED, Fluorescent lamps
Eligibility 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.
Sites / Locations
- CNRHP, Saint Antoine Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
LEDDYBLOO®
Double BILITRON®
Futura®
Arm Description
LEDDYBLOO® phototherapy device equipped with 20 at 30 blue and white LEDs
Double BILITRON® phototherapy corresponding to two small ramps associated together each one equipped of 5 blue LEDS
Future phototherapy device equipped with 8 fluorescent tubes
Outcomes
Primary Outcome Measures
Bilirubinemia
Secondary Outcome Measures
Evolution of bilirubinemia according to the device used
Hyperbilirubinemia rebound according to the device used
Full Information
NCT ID
NCT01136577
First Posted
June 2, 2010
Last Updated
December 10, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01136577
Brief Title
Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn
Acronym
DELF
Official Title
Comparison of Light-emitting Diodes (LED) Phototherapy Versus Fluorescent Lamps Phototherapy for Treatment of Hyperbilirubinemia in Term Newborn
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbilirubinemia
Keywords
Jaundice, Hyperbilirubinemia, Phototherapy, term newborn, LED, Fluorescent lamps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEDDYBLOO®
Arm Type
Experimental
Arm Description
LEDDYBLOO® phototherapy device equipped with 20 at 30 blue and white LEDs
Arm Title
Double BILITRON®
Arm Type
Experimental
Arm Description
Double BILITRON® phototherapy corresponding to two small ramps associated together each one equipped of 5 blue LEDS
Arm Title
Futura®
Arm Type
Experimental
Arm Description
Future phototherapy device equipped with 8 fluorescent tubes
Intervention Type
Device
Intervention Name(s)
Phototherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bilirubinemia
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Evolution of bilirubinemia according to the device used
Time Frame
6, 12,24, 48, 72 hours
Title
Hyperbilirubinemia rebound according to the device used
Time Frame
24 and 48 hours after discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Cortey, Doctor
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
CNRHP, Saint Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
12. IPD Sharing Statement
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Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn
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