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NCT03055481 Clinical Trial

A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

Neonatal Jaundice Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03055481
Other study ID # 2016-04-8
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date January 31, 2022

Study information
Verified date September 2023
Source Nagoya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Days to 4 Days
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• High irradiance level of phototherapy
High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.
• Low irradiance level of phototherapy
Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength

Locations
Country Name City State
Japan Anjo Kosei Hospital Anjo Aichi
Japan Handa City Hospital Handa Aichi
Japan Hekinan Municipal Hospital Hekinan Aichi
Japan Kasugai Municipal Hospital Kasugai Aichi
Japan Japan Red Cross Nagoya Daiichi Hospital Nagoya Aichi
Japan Nagoya University Hospital Nagoya Aichi
Japan Ogaki Municipal Hospital Ogaki Gifu
Japan TOYOTA Memorial Hospital Toyota Aichi

Sponsors (1)
Lead Sponsor Collaborator
Nagoya University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retreatment rate of neonatal jaundice Treatment of neonatal jaundice again after finishing phototherapy. one month
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