HyperbilirubinemiaNCT00635375
Comparative Study of Phototherapy for Hyperbilirubinemia
A study testing LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy), Metal halide phototherapy (Spot PT metal halide phototherapy) and LED bank phototherapy (Natus neoBlue LED bank phototherapy) in people with Hyperbilirubinemia, run by GE Healthcare at 2 sites in United States.
Trial summary
Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care nurseries around the world. It is a condition in which there is too much bilirubin in the blood. Bilirubin is a substance that is naturally released when red blood cells break down. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Hyperbilirubinemia
- What is being tested?
- LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy), Metal halide phototherapy (Spot PT metal halide phototherapy) and LED bank phototherapy (Natus neoBlue LED bank phototherapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Aug 2008
- 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 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- > 23 0/7 weeks gestation
- > 500 grams
- Non-hemolytic or presumed physiologic jaundice (within the first 14 days of life)
Who cannot join
- Known congenital infection (proven bacterial or viral etiology)
- Known hemolytic diseases such as but not limited to ABO or Rh incompatibility, minor blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, or hereditary red blood cell membrane defects (Coombs or DAT positive)
- Suspected genetic, syndromic, or hepatic disorder-
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Tennessee
Knoxville, Tennessee, 37920
Christiana Hospital
Newark, Delaware, 19718
About this study
Official title: A Comparative Study Between BiliSoft Blue LED Fiberoptic Blanket Phototherapy, Giraffe Spot PT Phototherapy, Natus Blue LED Bank Light Phototherapy, and BiliSoft + Giraffe Spot PT Combination Therapy
Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care nurseries around the world. It is a condition in which there is too much bilirubin in the blood. Bilirubin is a substance that is naturally released when red blood cells break down. In the early newborn period, multiple factors lead to an abnormally elevated bilirubin level. Large amounts of bilirubin can circulate to tissues in the brain and may cause seizures or brain damage. About 6.1% of term newborns and a higher percentage of preterm newborns develop hyperbilirubinemia that requires treatment. Initiating treatment depends on many factors, including the cause of the hyperbilirubinemia, the level of serum indirect bilirubin, the rate of indirect bilirubin rise, and the age of the patient. The goal of treatment is to keep the level of bilirubin from rising to dangerous levels.
The bilirubin molecule absorbs light. Therefore, treatment of hyperbilirubinemia involves exposure of the baby's skin to special blue spectrum light. Phototherapy is globally recognized as the standard of care for treatment of elevated indirect hyperbilirubinemia in the neonatal period. This light exposure converts water-insoluble indirect bilirubin to a more easily excreted soluble molecule. Over the last five years, several devices have been introduced that emit high intensity light in the blue portion of the visible light spectrum. However, despite frequent use of such therapy, the effectiveness of different phototherapy devices has not been adequately compared. The objective of this study is to compare the efficacy of the blue LED fiberoptic phototherapy with the metal halide spot phototherapy versus blue LED bank light phototherapy versus a combination of tandem therapy on lowering to total serum bilirubin.
- Conditions
- Hyperbilirubinemia
- Being tested
- LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy), Metal halide phototherapy (Spot PT metal halide phototherapy), LED bank phototherapy (Natus neoBlue LED bank phototherapy), Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)
- Medical subject headings
- Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)Device
Also called BiliSoft blue LED fiberoptic blanket phototherapy
35-50 mW/cm2/nm
Metal halide phototherapy (Spot PT metal halide phototherapy)Device
Also called Spot PT metal halide phototherapy
29.3-57.6 mW/cm2/nm
LED bank phototherapy (Natus neoBlue LED bank phototherapy)Device
Also called Natus neoBlue LED bank phototherapy
12-35 mW/cm2/nm
Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)Device
Also called BiliSoft and Spot PT
29.3-57.6 mW/cm2/nm and 35-50 mW/cm2/nm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | LED fiberoptic blanket phototherapy Receives: Device: LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy) |
| 2 | Experimental | metal halide phototherapy Receives: Device: Metal halide phototherapy (Spot PT metal halide phototherapy) |
| 3 | Active comparator | LED bank phototherapy Receives: Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy) |
| 4 | Experimental | Combination metal halide phototherapy plus LED fiberoptic blanket phototherapy Receives: Device: Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The LED Fiberoptic Phototherapy System and metal halide spot phototherapy are will show no difference in therapeutic treatment times compared to the LED Bank Light System.
Measured: 14 months
Secondary outcomes (1)
Combination Phototherapy Systems will show a 20% shorter treatment time compared to single treatment methods alone.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2008
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.
- More trials run by GE HealthcareThe 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wendy Sturtz, MD, Principal investigator, Christiana Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635375
- Sponsor's protocol ID
- 8828882
- Status last verified
- Jan 2009
- First submitted
- 5 Mar 2008
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between BiliSoft Blue LED Fiberoptic Blanket Phototherapy, Giraffe Spot PT Phototherapy, Natus Blue LED Bank Light Phototherapy, and BiliSoft + Giraffe Spot PT Combination Therapy
- ClinicalTrials.gov ID
- NCT00635375
- Acronym / sponsor ID
- 8828882
- Conditions
- Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Mar 2008 (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.
Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care nurseries around the world. It is a condition in which there is too much bilirubin in the blood. Bilirubin is a substance that is naturally released when red blood cells break down. In the early newborn period, multiple factors lead to an abnormally elevated bilirubin level. Large amounts of bilirubin can circulate to tissues in the brain and may cause seizures or brain damage. About 6.1% of term newborns and a higher percentage of preterm newborns develop hyperbilirubinemia that requires treatment. Initiating treatment depends on many factors, including the cause of the hyperbilirubinemia, the level of serum indirect bilirubin, the rate of indirect bilirubin rise, and the age of the patient. The goal of treatment is to keep the level of bilirubin from rising to dangerous levels.
The bilirubin molecule absorbs light. Therefore, treatment of hyperbilirubinemia involves exposure of the baby's skin to special blue spectrum light. Phototherapy is globally recognized as the standard of care for treatment of elevated indirect hyperbilirubinemia in the neonatal period. This light exposure converts water-insoluble indirect bilirubin to a more easily excreted soluble molecule. Over the last five years, several devices have been introduced that emit high intensity light in the blue portion of the visible light spectrum. However, despite frequent use of such therapy, the effectiveness of different phototherapy devices has not been adequately compared. The objective of this study is to compare the efficacy of the blue LED fiberoptic phototherapy with the metal halide spot phototherapy versus blue LED bank light phototherapy versus a combination of tandem therapy on lowering to total serum bilirubin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)LED fiberoptic blanket phototherapy |
| 2 | Experimental | Device: Metal halide phototherapy (Spot PT metal halide phototherapy)metal halide phototherapy |
| 3 | Active comparator | Device: LED bank phototherapy (Natus neoBlue LED bank phototherapy)LED bank phototherapy |
| 4 | Experimental | Device: Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)Combination metal halide phototherapy plus LED fiberoptic blanket phototherapy |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- > 23 0/7 weeks gestation
- > 500 grams
- Non-hemolytic or presumed physiologic jaundice (within the first 14 days of life)
Key exclusion criteria (3 listed)
- Known congenital infection (proven bacterial or viral etiology)
- Known hemolytic diseases such as but not limited to ABO or Rh incompatibility, minor blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, or hereditary red blood cell membrane defects (Coombs or DAT positive)
- Suspected genetic, syndromic, or hepatic disorder-
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 |
|---|---|---|
| LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy)Also: BiliSoft blue LED fiberoptic blanket phototherapy35-50 mW/cm2/nm | Device | 1 |
| Metal halide phototherapy (Spot PT metal halide phototherapy)Also: Spot PT metal halide phototherapy29.3-57.6 mW/cm2/nm | Device | 2 |
| LED bank phototherapy (Natus neoBlue LED bank phototherapy)Also: Natus neoBlue LED bank phototherapy12-35 mW/cm2/nm | Device | 3 |
| Metal halide plus LED fiberoptic blanket phototherapy (BiliSoft and Spot PT)Also: BiliSoft and Spot PT29.3-57.6 mW/cm2/nm and 35-50 mW/cm2/nm | Device | 4 |
Primary outcome
The LED Fiberoptic Phototherapy System and metal halide spot phototherapy are will show no difference in therapeutic treatment times compared to the LED Bank Light System.
Time frame: 14 months
1 secondary outcome
Combination Phototherapy Systems will show a 20% shorter treatment time compared to single treatment methods alone.
Time frame: 14 months
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 13 Jan 2009.
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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.
Wendy Sturtz, MD principal investigator
Christiana Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED fiberoptic blanket phototherapy (BiliSoft blue LED fiberoptic blanket phototherapy), Metal halide phototherapy (Spot PT metal halide phototherapy) and LED bank phototherapy (Natus neoBlue LED bank phototherapy) in people with Hyperbilirubinemia, run by GE Healthcare at 2 sites in United States.
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 3 inclusion and 3 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 13 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The LED Fiberoptic Phototherapy System and metal halide spot phototherapy are will show no difference in therapeutic treatment times compared to the LED Bank Light System. (time frame: 14 months). 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 13 Jan 2009.