NCT03055481

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Nagoya University · Academic / Other
• Sex: All
• Age: 2 Days – 4 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Jaundice

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-01
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2017-02-16
• Last updated: 2023-10-03

Locations

8 sites across 1 country: Japan