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

Not Applicable

Completed

• Conditions: Neonatal Hyperbilirubinemia
• Interventions: Other: Phototherapy with blue light

• Registration Number: NCT01470820
• Lead Sponsor: University of Aarhus

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-11
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-10
• Last Update Submitted: 2011-11-10
• Study First Posted: 2011-11-11
• Last Update Posted: 2011-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Gestational age ≥ 33 weeks
• Uncomplicated neonatal hyperbilirubinemia

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Exclusion Criteria

• < 33 weeks
• infants in incubators

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distance 20 cm	Phototherapy with blue light	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.
Distance 29 cm	Phototherapy with blue light	-
Distance 38 cm	Phototherapy with blue light	-
Distance 47 cm	Phototherapy with blue light	-

Primary Outcome Measures

Name	Time	Method
24 hours decrease of TsB expressed in percent.	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(%).

Trial Locations

Locations (1)

Pediatric Department, Aalborg Sygehus, Aarhus University Hospital; 🇩🇰 Aalborg, Denmark