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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 (%)).


Detailed Summary:
Sponsor: University of Aarhus

Current 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(%).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Aarhus

Dates:
Date Received: November 4, 2011
Date Started: July 2009
Date Completion:
Last Updated: November 10, 2011
Last Verified: November 2011