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.

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 (%)).

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Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

33 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Department, Aalborg Sygehus, Aarhus University Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Gestational age ≥ 33 weeks
Uncomplicated neonatal hyperbilirubinemia

Exclusion criteria

< 33 weeks
infants in incubators

Treatment and study plan

Phototherapy with blue light

Other

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 outcomes

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(%).

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Aarhus University Hospital

Registry information

Official study title

Dose-response Relationship of Phototherapy for Hyperbilirubinaemia Using Diodes: is There a "Saturation Point"?

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Nov 11, 2011
Registry last updated: Nov 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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