Study Stopped
it was estimated that the recruitment of the planned number of patients could not be completed within further 5 years.
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
1 other identifier
interventional
100
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedOctober 3, 2023
September 1, 2023
4.6 years
February 14, 2017
September 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retreatment rate of neonatal jaundice
Treatment of neonatal jaundice again after finishing phototherapy.
one month
Study Arms (2)
High level irradiation
ACTIVE COMPARATORHigh level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength.
Low level irradiation
EXPERIMENTALLow level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength.
Interventions
High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.
Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength
Eligibility Criteria
You may qualify if:
- Asian full-term neonates with jaundice between 48 and 96 hours of age.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Anjo Kosei Hospital
Anjo, Aichi-ken, 446-8602, Japan
Handa City Hospital
Handa, Aichi-ken, 475-8599, Japan
Hekinan Municipal Hospital
Hekinan, Aichi-ken, 447-8502, Japan
Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510, Japan
Japan Red Cross Nagoya Daiichi Hospital
Nagoya, Aichi-ken, 453-8511, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550, Japan
TOYOTA Memorial Hospital
Toyota, Aichi-ken, 471-8513, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
February 14, 2017
First Posted
February 16, 2017
Study Start
July 1, 2017
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
October 3, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share