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Trial record 2 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Jaundice"

A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

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ClinicalTrials.gov Identifier: NCT03055481
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yoshiaki Sato, Nagoya University

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.

Condition or disease Intervention/treatment Phase
Neonatal Jaundice Other: High irradiance level of phototherapy Other: Low irradiance level of phototherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Non-inferiority Randomized Controlled Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : February 20, 2019
Estimated Study Completion Date : February 20, 2020

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




Primary Outcome Measures :
  1. Retreatment rate of neonatal jaundice [ Time Frame: one month ]
    Treatment of neonatal jaundice again after finishing phototherapy.



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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055481


Contacts
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Contact: Kazuhiro Horiba, MD +81-52-741-2111 khoriba@med.nagoya-u.ac.jp
Contact: Yoshiaki Sato, MD,PhD +81-52-741-2111 yoshiaki@med.nagoya-u.ac.jp

Locations
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Japan
Anjo Kosei Hospital Active, not recruiting
Anjo, Aichi, Japan, 446-8602
Handa City Hospital Recruiting
Handa, Aichi, Japan, 475-8599
Hekinan Municipal Hospital Recruiting
Hekinan, Aichi, Japan, 447-8502
Kasugai Municipal Hospital Recruiting
Kasugai, Aichi, Japan, 486-8510
Japan Red Cross Nagoya Daiichi Hospital Recruiting
Nagoya, Aichi, Japan, 453-8511
Nagoya University Hospital Recruiting
Nagoya, Aichi, Japan, 466-8550
Contact: Yoshiaki Sato    +81-52-744-2294    yoshiaki@med.nagoya-u.ac.jp   
Contact: Kazuhiro Horiba    +81-52-744-2294    khoriba@med.nagoya-u.ac.jp   
TOYOTA Memorial Hospital Recruiting
Toyota, Aichi, Japan, 471-8513
Ogaki Municipal Hospital Recruiting
Ogaki, Gifu, Japan, 503-8502
Sponsors and Collaborators
Nagoya University

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Responsible Party: Yoshiaki Sato, Associate professor, Nagoya University
ClinicalTrials.gov Identifier: NCT03055481     History of Changes
Other Study ID Numbers: 2016-04-8
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yoshiaki Sato, Nagoya University:
neonatal jaundice
phototherapy
neonate

Additional relevant MeSH terms:
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Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases