Clinical Trial: A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Nagoya University

Current Primary Outcome: Retreatment rate of neonatal jaundice [ Time Frame: one month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Nagoya University

Dates:
Date Received: February 14, 2017
Date Started: February 20, 2017
Date Completion: February 20, 2020
Last Updated: February 15, 2017
Last Verified: February 2017