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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03055481

Enrollment

100

Registered

2017-02-16

Start date

2017-07-01

Completion date

2022-01-31

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Jaundice

Keywords

neonatal jaundice, phototherapy, neonate

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.

Interventions

OTHERHigh irradiance level of phototherapy

High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.

OTHERLow irradiance level of phototherapy

Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Days to 4 Days

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.

Design outcomes

Primary

Measure	Time frame	Description
Retreatment rate of neonatal jaundice	one month	Treatment of neonatal jaundice again after finishing phototherapy.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026