A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

Not Applicable

Terminated

• Conditions: Neonatal Jaundice
• Interventions: Other: Low irradiance level of phototherapy; Other: High irradiance level of phototherapy

• Registration Number: NCT03055481
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-16
• Study Start: 2017-07-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-30
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Asian full-term neonates with jaundice between 48 and 96 hours of age.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low level irradiation	Low irradiance level of phototherapy	Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength.
High level irradiation	High irradiance level of phototherapy	High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength.

Primary Outcome Measures

Name	Time	Method
Retreatment rate of neonatal jaundice	one month	Treatment of neonatal jaundice again after finishing phototherapy.

Trial Locations

Locations (8)

TOYOTA Memorial Hospital; 🇯🇵 Toyota, Aichi, Japan

Handa City Hospital; 🇯🇵 Handa, Aichi, Japan

Hekinan Municipal Hospital; 🇯🇵 Hekinan, Aichi, Japan

Kasugai Municipal Hospital; 🇯🇵 Kasugai, Aichi, Japan

Ogaki Municipal Hospital; 🇯🇵 Ogaki, Gifu, Japan

Anjo Kosei Hospital; 🇯🇵 Anjo, Aichi, Japan

Japan Red Cross Nagoya Daiichi Hospital; 🇯🇵 Nagoya, Aichi, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan