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A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

Primary Purpose

Neonatal Jaundice

Status
Terminated
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
High irradiance level of phototherapy
Low irradiance level of phototherapy
Sponsored by
Nagoya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Jaundice focused on measuring neonatal jaundice, phototherapy, neonate

Eligibility Criteria

2 Days - 4 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anjo Kosei Hospital
  • Handa City Hospital
  • Hekinan Municipal Hospital
  • Kasugai Municipal Hospital
  • Japan Red Cross Nagoya Daiichi Hospital
  • Nagoya University Hospital
  • TOYOTA Memorial Hospital
  • Ogaki Municipal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High level irradiation

Low level irradiation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Retreatment rate of neonatal jaundice
Treatment of neonatal jaundice again after finishing phototherapy.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2017
Last Updated
September 30, 2023
Sponsor
Nagoya University
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1. Study Identification

Unique Protocol Identification Number
NCT03055481
Brief Title
A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
Official Title
A Prospective Multicenter Non-inferiority Randomized Controlled Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
it was estimated that the recruitment of the planned number of patients could not be completed within further 5 years.
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice
Keywords
neonatal jaundice, phototherapy, neonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High level irradiation
Arm Type
Active Comparator
Arm Description
High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength.
Arm Title
Low level irradiation
Arm Type
Experimental
Arm Description
Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength.
Intervention Type
Other
Intervention Name(s)
High irradiance level of phototherapy
Intervention Description
High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.
Intervention Type
Other
Intervention Name(s)
Low irradiance level of phototherapy
Intervention Description
Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength
Primary Outcome Measure Information:
Title
Retreatment rate of neonatal jaundice
Description
Treatment of neonatal jaundice again after finishing phototherapy.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
4 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Anjo Kosei Hospital
City
Anjo
State/Province
Aichi
ZIP/Postal Code
446-8602
Country
Japan
Facility Name
Handa City Hospital
City
Handa
State/Province
Aichi
ZIP/Postal Code
475-8599
Country
Japan
Facility Name
Hekinan Municipal Hospital
City
Hekinan
State/Province
Aichi
ZIP/Postal Code
447-8502
Country
Japan
Facility Name
Kasugai Municipal Hospital
City
Kasugai
State/Province
Aichi
ZIP/Postal Code
486-8510
Country
Japan
Facility Name
Japan Red Cross Nagoya Daiichi Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
453-8511
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
TOYOTA Memorial Hospital
City
Toyota
State/Province
Aichi
ZIP/Postal Code
471-8513
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

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