Neonatal HyperbilirubinemiaNCT01470820
Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"
A study testing Phototherapy with blue light in people with Neonatal Hyperbilirubinemia, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: Using light emitting diodes (LED's) during conventional phototherapy it is possible to reduce the distance from light source to infant, thereby increasing light irradiance. Read more about this study
- Who is it for?
- Ages 33 weeks and older
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Phototherapy with blue light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2009to Dec 2010
- 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
- Gestational age ≥ 33 weeks
- Uncomplicated neonatal hyperbilirubinemia
Who cannot join
- < 33 weeks
- infants in incubators
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Pediatric Department, Aalborg Sygehus, Aarhus University Hospital
Aalborg, 9000
About this study
Official title: Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"?
Background: Using light emitting diodes (LED's) during conventional phototherapy it is possible to reduce the distance from light source to infant, thereby increasing light irradiance.
Objective: To examine the relation between light irradiance and the rate of decrease in total serum bilirubin concentration (TsB) and to see if the investigators can identify a "saturation point", i.e. an irradiation level above which there is no further decrease in TsB.
Read more
Design: Prospective randomised study. Setting: Neonatal Intensive Care Unit, Pediatric Department, Aalborg Hospital, Aarhus University Hospital, Denmark.
Material and method: 151 infants with gestational age ≥ 33 weeks and uncomplicated hyperbilirubinaemia are randomised to one of 4 different distances from phototherapy device to mattress (20, 29, 38 and 47 cm). TsB is measured before and after 24 hours of phototherapy and irradiance every 8th hour. Main outcome measure is 24 hours decrease of TsB expressed in percent (∆ TsB0-24 (%)).
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Phototherapy with blue light
- Keywords
- Neonates, Hyperbilirubinemia, Phototherapy, Light irradiance, Saturation point
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy with blue lightOther
The infants were placed in a bassinet with the phototherapy device placed above them. All infants were exposed naked (apart from eye pads and diaper) to continuously phototherapy for 24 hours, interrupted only for feeding and nursing for 30 minutes every three hours. TsB was determined before phototherapy and after 24 hours of treatment. The phototherapy apparatus used was neoBLUE LED phototherapy device (Natus Medical Inc., San Carlos, CA, USA) emitting blue light with an emission peak at 460 nm and a bandwidth of 450-470 nm. The irradiance was measured by use of the neoBLUE LED phototherapy radiometer (Natus Medical Inc.) every 8th hour at the infants head, trunk and knees and the average was calculated. The radiometer measures spectral irradiance in the range 420-500 nm with maximum sensitivity in the spectrum 440-480 nm.
| Study group | Role | What they receive |
|---|---|---|
| Distance 20 cm | Active comparator | The infants were randomized by sealed and opaque envelopes to one of four phototherapy regimens. Either with distance from the phototherapy device to the mattress of 20, 29, 38 or 47 cm measured by a wood stick for each infant, corresponding to the distances to the infants of averagely 12, 21, 30 and 39 cm, respectively. Receives: Other: Phototherapy with blue light |
| Distance 29 cm | Active comparator | Not described Receives: Other: Phototherapy with blue light |
| Distance 38 cm | Active comparator | Not described Receives: Other: Phototherapy with blue light |
| Distance 47 cm | Active comparator | Not described Receives: Other: Phototherapy with blue light |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours decrease of TsB expressed in percent.
TsB was measured before and after 24 hours of phototherapy and irradiance every 8th hour. Main outcome was 24 hours decrease of TsB expressed in percent (∆ TsB0-24(%).
Measured: Baseline and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJul 2009
- Primary completionDec 2010
- Study completionDec 2010
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 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Pernille K Vandborg, MD, Principal investigator, Pediatric department, Aalborg Sygehus, Aarhus University HospitalFinn Ebbesen, Professor, Principal investigator, Pediatric department, Aalborg Sygehus, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470820
- Sponsor's protocol ID
- N-20090014
- Status last verified
- Nov 2011
- First submitted
- 4 Nov 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Vandborg PK, Hansen BM, Greisen G, Ebbesen F. Dose-response relationship of phototherapy for hyperbilirubinemia. Pediatrics. 2012 Aug;130(2):e352-7. doi: 10.1542/peds.2011-3235. Epub 2012 Jul 16.
PubMed 22802603
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"?
- ClinicalTrials.gov ID
- NCT01470820
- Acronym / sponsor ID
- N-20090014
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- Neonates, Hyperbilirubinemia, Phototherapy, Light irradiance, Saturation point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Jul 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Nov 2011 (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.
Background: Using light emitting diodes (LED's) during conventional phototherapy it is possible to reduce the distance from light source to infant, thereby increasing light irradiance.
Objective: To examine the relation between light irradiance and the rate of decrease in total serum bilirubin concentration (TsB) and to see if the investigators can identify a "saturation point", i.e. an irradiation level above which there is no further decrease in TsB.
Design: Prospective randomised study. Setting: Neonatal Intensive Care Unit, Pediatric Department, Aalborg Hospital, Aarhus University Hospital, Denmark.
Material and method: 151 infants with gestational age ≥ 33 weeks and uncomplicated hyperbilirubinaemia are randomised to one of 4 different distances from phototherapy device to mattress (20, 29, 38 and 47 cm). TsB is measured before and after 24 hours of phototherapy and irradiance every 8th hour. Main outcome measure is 24 hours decrease of TsB expressed in percent (∆ TsB0-24 (%)).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Distance 20 cm | Active comparator | Other: Phototherapy with blue lightThe infants were randomized by sealed and opaque envelopes to one of four phototherapy regimens. Either with distance from the phototherapy device to the mattress of 20, 29, 38 or 47 cm measured by a wood stick for each infant, corresponding to the distances to the infants of averagely 12, 21, 30 and 39 cm, respectively. |
| Distance 29 cm | Active comparator | Other: Phototherapy with blue light |
| Distance 38 cm | Active comparator | Other: Phototherapy with blue light |
| Distance 47 cm | Active comparator | Other: Phototherapy with blue light |
Who may qualify
- Ages
- 33 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age ≥ 33 weeks
- Uncomplicated neonatal hyperbilirubinemia
Key exclusion criteria (2 listed)
- < 33 weeks
- infants in incubators
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 |
|---|---|---|
| Phototherapy with blue lightThe infants were placed in a bassinet with the phototherapy device placed above them. All infants were exposed naked (apart from eye pads and diaper) to continuously phototherapy for 24 hours, interrupted only for feeding and nursing for 30 minutes every three hours. TsB was determined before phototherapy and after 24 hours of treatment. The phototherapy apparatus used was neoBLUE LED phototherapy device (Natus Medical Inc., San Carlos, CA, USA) emitting blue light with an emission peak at 460 nm and a bandwidth of 450-470 nm. The irradiance was measured by use of the neoBLUE LED phototherapy radiometer (Natus Medical Inc.) every 8th hour at the infants head, trunk and knees and the average was calculated. The radiometer measures spectral irradiance in the range 420-500 nm with maximum sensitivity in the spectrum 440-480 nm. | Other | Distance 20 cm, Distance 29 cm, Distance 38 cm, Distance 47 cm |
Primary outcome
24 hours decrease of TsB expressed in percent.
Time frame: Baseline and 24 hours
TsB was measured before and after 24 hours of phototherapy and irradiance every 8th hour. Main outcome was 24 hours decrease of TsB expressed in percent (∆ TsB0-24(%).
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 11 Nov 2011.
- Derived from this study: PubMed 22802603Vandborg PK, Hansen BM, Greisen G, Ebbesen F. Dose-response relationship of phototherapy for hyperbilirubinemia. Pediatrics. 2012 Aug;130(2):e352-7. doi: 10.1542/peds.2011-3235. Epub 2012 Jul 16.
Related trials for Neonatal Hyperbilirubinemia
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Recruiting
Foot Reflexology and Massage in Neonates Receiving Phototherapy
Neonatal Hyperbilirubinemia
Active, not recruiting
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
Prematurity, Low Birth Weight
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
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.
Pernille K Vandborg, MD principal investigator
Pediatric department, Aalborg Sygehus, Aarhus University Hospital
Finn Ebbesen, Professor principal investigator
Pediatric department, Aalborg Sygehus, Aarhus 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 with blue light in people with 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 2 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 11 Nov 2011. 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?
24 hours decrease of TsB expressed in percent. (time frame: Baseline and 24 hours). 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 NCT01470820, 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 11 Nov 2011.