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

Not Applicable

Terminated

• Conditions: Hyperbilirubinemia
• Interventions: Device: Phototherapy

• Registration Number: NCT01136577
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2011-10
• Study Completion: 2012-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double BILITRON®	Phototherapy	Double BILITRON® phototherapy corresponding to two small ramps associated together each one equipped of 5 blue LEDS
Futura®	Phototherapy	Future phototherapy device equipped with 8 fluorescent tubes
LEDDYBLOO®	Phototherapy	LEDDYBLOO® phototherapy device equipped with 20 at 30 blue and white LEDs

Primary Outcome Measures

Name	Time	Method
Bilirubinemia	24 hours

Secondary Outcome Measures

Name	Time	Method
Evolution of bilirubinemia according to the device used	6, 12,24, 48, 72 hours
Hyperbilirubinemia rebound according to the device used	24 and 48 hours after discontinuation

Trial Locations

Locations (1)

CNRHP, Saint Antoine Hospital; 🇫🇷 Paris, France