Status:
TERMINATED
Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hyperbilirubinemia
Eligibility:
All Genders
35+ years
Phase:
NA
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...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01136577
Start Date
January 1 2010
End Date
March 1 2012
Last Update
December 11 2012
Active Locations (1)
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1
CNRHP, Saint Antoine Hospital
Paris, France, France, 75012