NCT01470820

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 33 Weeks
• Healthy volunteers: Not accepted

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 (%)).

Conditions

• Neonatal Hyperbilirubinemia

Interventions

Type	Name	Description
OTHER	Phototherapy with blue light	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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-11-11
• Last updated: 2011-11-11

Locations

1 site across 1 country: Denmark