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A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055481
Recruitment Status : Unknown
Verified January 2018 by Yoshiaki Sato, Nagoya University.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yoshiaki Sato, Nagoya University

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE February 16, 2017
Last Update Posted Date January 9, 2018
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2018)
Retreatment rate of neonatal jaundice [ Time Frame: one month ]
Treatment of neonatal jaundice again after finishing phototherapy.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Retreatment rate of neonatal jaundice [ Time Frame: one month ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
Official Title  ICMJE A Prospective Multicenter Non-inferiority Randomized Controlled Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neonatal Jaundice
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Active Comparator: High level irradiation
    High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength.
    Intervention: Other: High irradiance level of phototherapy
  • Experimental: Low level irradiation
    Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength.
    Intervention: Other: Low irradiance level of phototherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 20, 2020
Estimated Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03055481
Other Study ID Numbers  ICMJE 2016-04-8
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yoshiaki Sato, Nagoya University
Study Sponsor  ICMJE Nagoya University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nagoya University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP