A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

Study Overview
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Brief Summary
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The aim of this trial is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice.

Detailed Description
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Neonatal jaundice is a commonly disease. Phototherapy is performed to prevent from kernicterus.However, light sources and irradiance level are different among hospitals, and it was controversial whether the improvement of jaundice is related to the irradiance level of phototherapy or not. In addition, long-term side effects are not clear, therefore, excessive irradiation should be avoided. The purpose of this study is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice. This study is multicenter randomized controlled trial conducted by Nagoya University Hospital, Anjo Kosei Hospital, Kasugai Municipal Hospital, Handa Hospital, TOYOTA Memorial Hospital, National Hospital Organization Nagoya Medical Center, Japan Red Cross Nagoya Daiichi Hospital, Hekinan Municipal Hospital, and Ogaki Municipal Hospital.

Official Title
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A Prospective Multicenter Non-inferiority Randomized Controlled Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

Conditions
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Neonatal Jaundice

Intervention / Treatment
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* Other: High irradiance level of phototherapy
* Other: Low irradiance level of phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asian full-term neonates with jaundice between 48 and 96 hours of age. Exclusion Criteria: Patients with low-birth-weight, early onset jaundice before 48 hours of age, perinatal asphyxia, antimicrobial therapy or respiratory disorders. Patients with jaundice caused by hemolysis, or functional or anatomic obstruction. Patients who need treatments except for phototherapy.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 4 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High level irradiation<br>High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength. | Other: High irradiance level of phototherapy<br>* High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.<br>|
| Experimental: Low level irradiation<br>Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength. | Other: Low irradiance level of phototherapy<br>* Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retreatment rate of neonatal jaundice | Treatment of neonatal jaundice again after finishing phototherapy. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal jaundice, phototherapy, neonate