Neonatal JaundiceNCT03055481
A Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
A study testing High irradiance level of phototherapy and Low irradiance level of phototherapy in people with Neonatal Jaundice, run by Nagoya University at 8 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 4 days
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- High irradiance level of phototherapy and Low irradiance level of phototherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesJapan
- Study dates
- 1 Jul 2017to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Asian full-term neonates with jaundice between 48 and 96 hours of age.
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Anjo Kosei Hospital
Anjo, Aichi-ken, 446-8602
Handa City Hospital
Handa, Aichi-ken, 475-8599
Hekinan Municipal Hospital
Hekinan, Aichi-ken, 447-8502
Kasugai Municipal Hospital
Kasugai, Aichi-ken, 486-8510
Japan Red Cross Nagoya Daiichi Hospital
Nagoya, Aichi-ken, 453-8511
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502
TOYOTA Memorial Hospital
Toyota, Aichi-ken, 471-8513
About this study
Official title: A Prospective Multicenter Non-inferiority Randomized Controlled Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
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.
Read the 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
- Being tested
- High irradiance level of phototherapy, Low irradiance level of phototherapy
- Keywords
- neonatal jaundice, phototherapy, neonate
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High irradiance level of phototherapyOther
High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.
Low irradiance level of phototherapyOther
Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength
| Study group | Role | What they receive |
|---|---|---|
| High level irradiation | Active comparator | High level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength. Receives: Other: High irradiance level of phototherapy |
| Low level irradiation | Experimental | Low level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength. Receives: Other: Low irradiance level of phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retreatment rate of neonatal jaundice
Treatment of neonatal jaundice again after finishing phototherapy.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Jul 2017
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Why it stopped: it was estimated that the recruitment of the planned number of patients could not be completed within further 5 years.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshiaki Sato, Nagoya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055481
- Sponsor's protocol ID
- 2016-04-8
- Status last verified
- Sep 2023
- First submitted
- 14 Feb 2017
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Non-inferiority Randomized Controlled Trial of the Irradiance Level of Phototherapy for Neonatal Jaundice
- ClinicalTrials.gov ID
- NCT03055481
- Acronym / sponsor ID
- 2016-04-8
- Conditions
- Neonatal Jaundice
- Keywords
- neonatal jaundice, phototherapy, neonate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: it was estimated that the recruitment of the planned number of patients could not be completed within further 5 years.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High level irradiation | Active comparator | Other: High irradiance level of phototherapyHigh level irradiation: the target irradiance level is 30-35uW per square centimeter per nano-meter of wavelength. |
| Low level irradiation | Experimental | Other: Low irradiance level of phototherapyLow level irradiation: the target irradiance level is 12-15uW per square centimeter per nano-meter of wavelength. |
Who may qualify
- Ages
- 2 to 4 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Asian full-term neonates with jaundice between 48 and 96 hours of age.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High irradiance level of phototherapyHigh irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength. | Other | High level irradiation |
| Low irradiance level of phototherapyLow irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength | Other | Low level irradiation |
Primary outcome
Retreatment rate of neonatal jaundice
Time frame: one month
Treatment of neonatal jaundice again after finishing phototherapy.
Results and safety
The study was stopped early (reason given: it was estimated that the recruitment of the planned number of patients could not be completed within further 5 years.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High irradiance level of phototherapy and Low irradiance level of phototherapy in people with Neonatal Jaundice, run by Nagoya University at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: it was estimated that the recruitment of the planned number of patients could not be completed within further 5 years.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retreatment rate of neonatal jaundice (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.