Neonatal Hyperbilirubinemia Clinical Trial
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.
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 (%)).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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