A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2022-01-31

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.

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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.

Conditions

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Neonatal Jaundice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High level irradiation

High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength.

Group Type ACTIVE_COMPARATOR

High irradiance level of phototherapy

Intervention Type OTHER

High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.

Low level irradiation

Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength.

Group Type EXPERIMENTAL

Low irradiance level of phototherapy

Intervention Type OTHER

Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength

Interventions

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High irradiance level of phototherapy

High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.

Intervention Type OTHER

Low irradiance level of phototherapy

Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength

Intervention Type OTHER

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.

Minimum Eligible Age

2 Days

Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No