Neonatal JaundiceNCT03183986
Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.
A study testing Phototherapy in people with Neonatal Jaundice, run by University of Aarhus at 1 site in Denmark.
Trial summary
Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. Read more about this study
- Who is it for?
- Ages 25 hours to 28 days
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 1 Jul 2018
- 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 25 hours to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Indication for phototherapy with single light
- Gestational age > 33 weeks
- Birth weight > 1800 grams
- Should be treatable in a cradle
Who cannot join
- Haemolytic disease
- Indication for double/triple phototherapy or exchange transfusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Neonatal department, Aalborg University Hospital
Aalborg, 9000
Mette Donneborg, MD, +45 22406344, mld@rn.dk
Finn Ebbesen, Professor, MD, + 45 97663330, fe@rn.dk
About this study
Official title: Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.
Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. The aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478 vs. 459 nm., respectively.
Read the detailed description
This is a prospective randomised study of the efficacy of phototherapy. Inclusion criteria are gestational age > 33 weeks and birth weight > 1800 grams, uncomplicated neonatal jaundice. The infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. Exclusion criteria is haemolytic disease. Total serum bilirubin (TSB) is measured before and after 24 hours of phototherapy. The infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes.
Power calculation based on expected difference in decrease of TSB of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.
- Conditions
- Neonatal Jaundice
- Being tested
- Phototherapy
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyDevice
Phototherapy for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy 478 nm | Active comparator | The jaundiced neonates receives phototherapy with blue light from above at wavelength 478 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice. Receives: Device: Phototherapy |
| Phototherapy 459 nm | Active comparator | The jaundiced neonates receives phototherapy with blue light from above at wavelength 459 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice. Receives: Device: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of total serum bilirubin
Measured: 24 hours of phototherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies 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
- Single group
- Model description
- Infants are randomised to phototherapy with blue LED's with wavelength of 478 or 459 nm. The decrease of TSB between the groups is compared.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Pernille Kure Vandborg, University of Aarhus
- Investigators
- Mette Donneborg, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183986
- Sponsor's protocol ID
- N-20160071
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lamola AA. A Pharmacologic View of Phototherapy. Clin Perinatol. 2016 Jun;43(2):259-76. doi: 10.1016/j.clp.2016.01.004. Epub 2016 Feb 15.
PubMed 27235206
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.
- ClinicalTrials.gov ID
- NCT03183986
- Acronym / sponsor ID
- N-20160071
- Conditions
- Neonatal Jaundice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 12 Jun 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.
Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. The aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478 vs. 459 nm., respectively.
Detailed description
This is a prospective randomised study of the efficacy of phototherapy. Inclusion criteria are gestational age > 33 weeks and birth weight > 1800 grams, uncomplicated neonatal jaundice. The infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. Exclusion criteria is haemolytic disease. Total serum bilirubin (TSB) is measured before and after 24 hours of phototherapy. The infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes.
Power calculation based on expected difference in decrease of TSB of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants are randomised to phototherapy with blue LED's with wavelength of 478 or 459 nm. The decrease of TSB between the groups is compared.
| Arm | Type | Receives |
|---|---|---|
| Phototherapy 478 nm | Active comparator | Device: PhototherapyThe jaundiced neonates receives phototherapy with blue light from above at wavelength 478 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice. |
| Phototherapy 459 nm | Active comparator | Device: PhototherapyThe jaundiced neonates receives phototherapy with blue light from above at wavelength 459 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice. |
Who may qualify
- Ages
- 25 hours to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Indication for phototherapy with single light
- Gestational age > 33 weeks
- Birth weight > 1800 grams
- Should be treatable in a cradle
Key exclusion criteria (2 listed)
- Haemolytic disease
- Indication for double/triple phototherapy or exchange transfusion
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 |
|---|---|---|
| PhototherapyPhototherapy for 24 hours. | Device | Phototherapy 459 nm, Phototherapy 478 nm |
Primary outcome
Decrease of total serum bilirubin
Time frame: 24 hours of phototherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Background: PubMed 27235206Lamola AA. A Pharmacologic View of Phototherapy. Clin Perinatol. 2016 Jun;43(2):259-76. doi: 10.1016/j.clp.2016.01.004. Epub 2016 Feb 15.
- 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.
Mette Donneborg, MD principal investigator
Aalborg University Hospital
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 Neonatal Jaundice, 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 4 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pernille K Vandborg, MD, PhD (+ 45 26131711, pervan@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of total serum bilirubin (time frame: 24 hours of phototherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03183986, which also lists 1 linked publication.
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 20 Jun 2017.