Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"
Primary Purpose
Neonatal Hyperbilirubinemia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Phototherapy with blue light
Sponsored by
About this trial
This is an interventional health services research trial for Neonatal Hyperbilirubinemia focused on measuring Neonates, Hyperbilirubinemia, Phototherapy, Light irradiance, Saturation point
Eligibility Criteria
Inclusion Criteria:
- Gestational age ≥ 33 weeks
- Uncomplicated neonatal hyperbilirubinemia
Exclusion Criteria:
- < 33 weeks
- infants in incubators
Sites / Locations
- Pediatric Department, Aalborg Sygehus, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Distance 20 cm
Distance 29 cm
Distance 38 cm
Distance 47 cm
Arm Description
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.
Outcomes
Primary Outcome Measures
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(%).
Secondary Outcome Measures
Full Information
NCT ID
NCT01470820
First Posted
November 4, 2011
Last Updated
November 10, 2011
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01470820
Brief Title
Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"
Official Title
Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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 (%)).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia
Keywords
Neonates, Hyperbilirubinemia, Phototherapy, Light irradiance, Saturation point
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Distance 20 cm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Distance 29 cm
Arm Type
Active Comparator
Arm Title
Distance 38 cm
Arm Type
Active Comparator
Arm Title
Distance 47 cm
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Phototherapy with blue light
Intervention Description
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.
Primary Outcome Measure Information:
Title
24 hours decrease of TsB expressed in percent.
Description
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(%).
Time Frame
Baseline and 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age ≥ 33 weeks
Uncomplicated neonatal hyperbilirubinemia
Exclusion Criteria:
< 33 weeks
infants in incubators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille K Vandborg, MD
Organizational Affiliation
Pediatric department, Aalborg Sygehus, Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Finn Ebbesen, Professor
Organizational Affiliation
Pediatric department, Aalborg Sygehus, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Department, Aalborg Sygehus, Aarhus University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22802603
Citation
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.
Results Reference
derived
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Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"
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