HyperbilirubinemiaNCT02805296
High Intensity Phototherapy: Double vs. Single
A study testing Light irradiance in people with Hyperbilirubinemia, run by Aalborg University Hospital.
Trial summary
Intensive phototherapy in form of double light is used worldwide in the treatment of severe neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the efficiency of phototherapy. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Hyperbilirubinemia
- What is being tested?
- Light irradiance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Aug 2015
- 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 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Otherwise healthy newborn infants with hyperbilirubinemia without signs of hemolytic disease
- gestational age ≥33 weeks
- birth weight ≥1800 g
- The infants should be treatable in a cradle
Who cannot join
- Infants fulfilling the indications for exchange transfusion or double phototherapy due to a very high initial or rapidly increasing TsB will not be enrolled.
About this study
Official title: Intensive Phototherapy, Double vs. Single, in Treatment of Neonatal Hyperbilirubinemia Using LED
Intensive phototherapy in form of double light is used worldwide in the treatment of severe neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the efficiency of phototherapy. This study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using light emitting diodes, and whether there is an upper limit for the efficacy of phototherapy.
Read the detailed description
Hyperbilirubinemia occurs in 60 - 80 % of newborns during the first days of life, among others because of immaturity of the enzyme uridin-glukuronosyl-transferase (UGT1A1) in the liver. In seldom cases with very high total serum bilirubin concentration (TsB), bilirubin can cross the blood-brain barrier and the deposition of unconjugated bilirubin in the central nervous system may cause acute bilirubin encephalopathy (ABE). This can progress to chronic bilirubin encephalopathy (CBE), a devastating condition, which unfortunately still occurs, even in industrialised countries.
Hyperbilirubinemia gets severe for 2 - 6 % of infants born at term or late preterm, which means, they need treatment to prevent ABE and the treatment of choice is phototherapy due to its efficacy and safety. Hereby bilirubin in the skin and plasma is converted to photobilirubins; they are water-soluble and can be excreted through the liver without conjugation. They are presumably non-toxic. In most departments, single phototherapy is first choice. To avoid the above-mentioned damaging condition, it is very important to optimize phototherapy.
Former fluorescent tubes were used as light source, but now light emission diodes (LED) are used.
This study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using LED, and whether there is an upper limit for the efficacy of phototherapy.
It is a prospective, randomised controlled study. The infants will be randomized to either 1: Conventional phototherapy with blue LED light from above and a distance from light source to mattress of 30 cm, giving a light irradiance of 66 µW/cm2/nm or 2: Conventional phototherapy combined with a light blanket (Bilisoft) with a light irradiance by the skin of 39 µW/cm2/nm. TsB will be measured at start and after 12 - and 24 h of treatment. Based on the calculation of strength 72 infants will be needed in this study. As statistical methods t-tests will be used and multiple linear regression models will be used to adjust for confounding.
- Conditions
- Hyperbilirubinemia
- Being tested
- Light irradiance
- Medical subject headings
- Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light irradianceOther
Comparison of double vs. single phototherapy
| Study group | Role | What they receive |
|---|---|---|
| Double light | Active comparator | High-intensity phototherapy with blue LED light from above combined with a fiber optic, blue LED blanket from below.
Intervention: Light irradiance: 66 µW/cm2/nm + 39 µW/cm2/nm Receives: Other: Light irradiance |
| Single light | Active comparator | High-intensity phototherapy with blue LED light from above. Intervention: Light irradiance: 66 µW/cm2/nm Receives: Other: Light irradiance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in total serum bilirubin after 12- and 24 hours of phototherapy, measured in percent.
Total serum bilirubin will be measured at start of phototherapy, after 12 - and after 24 hours of phototherapy for both Groups. Primary outcome measure is, whether double phototherapy decreases total serum bilirubin faster than single phototherapy after 12- and/or after 24 hours of phototherapy.
Measured: 12 and 24 Hours og phototherapy
Secondary outcomes (1)
Whether total serum bilirubin continues to decrease measured in percent after 24 hours of high-intensity phototherapy
To figure out, whether there is an upper limit for the efficacy of phototherapy, i.e. a plateau above which total serum bilirubin does not decrease any further.
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 posted20 Jun 2016 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperbilirubinemiaStudies 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mette L Roed, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805296
- Sponsor's protocol ID
- N-20140010
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Phototherapy, Double vs. Single, in Treatment of Neonatal Hyperbilirubinemia Using LED
- ClinicalTrials.gov ID
- NCT02805296
- Acronym / sponsor ID
- N-20140010
- Conditions
- Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Jun 2016 (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.
Intensive phototherapy in form of double light is used worldwide in the treatment of severe neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the efficiency of phototherapy. This study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using light emitting diodes, and whether there is an upper limit for the efficacy of phototherapy.
Detailed description
Hyperbilirubinemia occurs in 60 - 80 % of newborns during the first days of life, among others because of immaturity of the enzyme uridin-glukuronosyl-transferase (UGT1A1) in the liver. In seldom cases with very high total serum bilirubin concentration (TsB), bilirubin can cross the blood-brain barrier and the deposition of unconjugated bilirubin in the central nervous system may cause acute bilirubin encephalopathy (ABE). This can progress to chronic bilirubin encephalopathy (CBE), a devastating condition, which unfortunately still occurs, even in industrialised countries.
Hyperbilirubinemia gets severe for 2 - 6 % of infants born at term or late preterm, which means, they need treatment to prevent ABE and the treatment of choice is phototherapy due to its efficacy and safety. Hereby bilirubin in the skin and plasma is converted to photobilirubins; they are water-soluble and can be excreted through the liver without conjugation. They are presumably non-toxic. In most departments, single phototherapy is first choice. To avoid the above-mentioned damaging condition, it is very important to optimize phototherapy.
Former fluorescent tubes were used as light source, but now light emission diodes (LED) are used.
This study investigates whether double phototherapy reduces total serum bilirubin faster than single light during intensive phototherapy, using LED, and whether there is an upper limit for the efficacy of phototherapy.
It is a prospective, randomised controlled study. The infants will be randomized to either 1: Conventional phototherapy with blue LED light from above and a distance from light source to mattress of 30 cm, giving a light irradiance of 66 µW/cm2/nm or 2: Conventional phototherapy combined with a light blanket (Bilisoft) with a light irradiance by the skin of 39 µW/cm2/nm. TsB will be measured at start and after 12 - and 24 h of treatment. Based on the calculation of strength 72 infants will be needed in this study. As statistical methods t-tests will be used and multiple linear regression models will be used to adjust for confounding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double light | Active comparator | Other: Light irradianceHigh-intensity phototherapy with blue LED light from above combined with a fiber optic, blue LED blanket from below. Intervention: Light irradiance: 66 µW/cm2/nm + 39 µW/cm2/nm |
| Single light | Active comparator | Other: Light irradianceHigh-intensity phototherapy with blue LED light from above. Intervention: Light irradiance: 66 µW/cm2/nm |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Otherwise healthy newborn infants with hyperbilirubinemia without signs of hemolytic disease
- gestational age ≥33 weeks
- birth weight ≥1800 g
- The infants should be treatable in a cradle
Key exclusion criteria (1 listed)
- Infants fulfilling the indications for exchange transfusion or double phototherapy due to a very high initial or rapidly increasing TsB will not be enrolled.
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 |
|---|---|---|
| Light irradianceComparison of double vs. single phototherapy | Other | Double light, Single light |
Primary outcome
Decrease in total serum bilirubin after 12- and 24 hours of phototherapy, measured in percent.
Time frame: 12 and 24 Hours og phototherapy
Total serum bilirubin will be measured at start of phototherapy, after 12 - and after 24 hours of phototherapy for both Groups. Primary outcome measure is, whether double phototherapy decreases total serum bilirubin faster than single phototherapy after 12- and/or after 24 hours of phototherapy.
1 secondary outcome
Whether total serum bilirubin continues to decrease measured in percent after 24 hours of high-intensity phototherapy
Time frame: 24 Hours of phototherapy
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 20 Jun 2016.
- 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 L Roed, MD principal investigator
Aalborg University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Light irradiance in people with Hyperbilirubinemia, run by Aalborg University Hospital.
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 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: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 after 12- and 24 hours of phototherapy, measured in percent. (time frame: 12 and 24 Hours og phototherapy). 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 20 Jun 2016.