A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

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

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.

Study Overview

• Status: Terminated
• Conditions: Neonatal Jaundice
• Intervention / Treatment: Other: High irradiance level of phototherapy; Other: Low irradiance level of phototherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kazuhiro Horiba, MD,PhD; Phone Number: +81-52-741-2111; Email: khoriba@med.nagoya-u.ac.jp
• Study Contact Backup: Name: Yoshiaki Sato, MD,PhD; Phone Number: +81-52-741-2111; Email: yoshiaki@med.nagoya-u.ac.jp

Study Locations

• Japan
  • Aichi
    • Anjo, Aichi, Japan, 446-8602
      • Anjo Kosei Hospital
    • Handa, Aichi, Japan, 475-8599
      • Handa City Hospital
    • Hekinan, Aichi, Japan, 447-8502
      • Hekinan Municipal Hospital
    • Kasugai, Aichi, Japan, 486-8510
      • Kasugai Municipal Hospital
    • Nagoya, Aichi, Japan, 466-8550
      • Nagoya University Hospital
    • Nagoya, Aichi, Japan, 453-8511
      • Japan Red Cross Nagoya Daiichi Hospital
    • Toyota, Aichi, Japan, 471-8513
      • Toyota Memorial Hospital
  • Gifu
    • Ogaki, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 4 days (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High level irradiation; High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength.	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.
Experimental: Low level irradiation; Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength.	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nagoya University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 30, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: phototherapy; neonate; neonatal jaundice
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: 2016-04-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No