Uncomplicated Neonatal HyperbilirubinemiaNCT02154165
Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes
A study testing Phototherapy in people with Uncomplicated Neonatal Hyperbilirubinemia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Read more about this study
- Who is it for?
- Ages 33 weeks and older
- Conditions the study is for
- Uncomplicated Neonatal Hyperbilirubinemia
- What is being tested?
- Phototherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Dec 2013
- 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 33 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newborns with gestational age >33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines
Who cannot join
- Haemolytic disease (Rhesus and Kell blood type isoimmunization, spherocytosis)
- Liver disease
Trial locations and contacts
1 site in 1 country.
About this study
The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Though, previous studies used light tubes, today we use light emitting diodes (LED'S).
The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus blue LED's for decreasing total serum bilirubin in neonates with gestational age > 33 weeks and uncomplicated hyperbilirubinemia.
- Being tested
- Phototherapy
- Keywords
- Neonatal hyperbilirubinemia, Phototherapy, Light emitting diodes, Blue light, Turquoise light
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyOther
The infants were randomized to phototherapy with either blue og turquoise light
| Study group | Role | What they receive |
|---|---|---|
| Blue light wavelenght 460 nm | Active comparator | Not described Receives: Other: Phototherapy |
| Turquoise light wavelength 499 nm | Active comparator | Not described Receives: Other: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in total serum bilirubin
The infants were treated with phototherapy for 24 hours, which is the standard treatment.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helene Nørrelund, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154165
- Sponsor's protocol ID
- PKV 2013
- Status last verified
- May 2014
- First submitted
- 30 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes
- ClinicalTrials.gov ID
- NCT02154165
- Acronym / sponsor ID
- PKV 2013
- Keywords
- Neonatal hyperbilirubinemia, Phototherapy, Light emitting diodes, Blue light, Turquoise light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jun 2014 (estimated)
- 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 optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Though, previous studies used light tubes, today we use light emitting diodes (LED'S).
The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus blue LED's for decreasing total serum bilirubin in neonates with gestational age > 33 weeks and uncomplicated hyperbilirubinemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue light wavelenght 460 nm | Active comparator | Other: Phototherapy |
| Turquoise light wavelength 499 nm | Active comparator | Other: Phototherapy |
Who may qualify
- Ages
- 33 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Newborns with gestational age >33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines
Key exclusion criteria (2 listed)
- Haemolytic disease (Rhesus and Kell blood type isoimmunization, spherocytosis)
- Liver disease
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 |
|---|---|---|
| PhototherapyThe infants were randomized to phototherapy with either blue og turquoise light | Other | Blue light wavelenght 460 nm, Turquoise light wavelength 499 nm |
Primary outcome
Decrease in total serum bilirubin
Time frame: 24 hours
The infants were treated with phototherapy for 24 hours, which is the standard treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy in people with Uncomplicated Neonatal Hyperbilirubinemia, run by University of Aarhus at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrease in total serum bilirubin (time frame: 24 hours). 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 Jun 2014.