A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice

Tokai National Higher Education and Research System

Status: Terminated

Conditions: Neonatal Jaundice

Treatments: Other: Low irradiance level of phototherapy; Other: High irradiance level of phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03055481

2016-04-8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 4 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

High level irradiation

Active Comparator group

Description:

High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength.

Treatment:

Other: High irradiance level of phototherapy

Low level irradiation

Experimental group

Description:

Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength.

Treatment:

Other: Low irradiance level of phototherapy