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

NCT01136577 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-12-11

No results posted yet for this study

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.

Conditions

  • Hyperbilirubinemia

Interventions

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Anne Cortey, Doctor · APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-10-31
Completion
2012-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01136577 on ClinicalTrials.gov