Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.

Study Overview
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Brief Summary
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Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. The aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478 vs. 459 nm., respectively.

Detailed Description
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This is a prospective randomised study of the efficacy of phototherapy. Inclusion criteria are gestational age > 33 weeks and birth weight > 1800 grams, uncomplicated neonatal jaundice. The infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. Exclusion criteria is haemolytic disease. Total serum bilirubin (TSB) is measured before and after 24 hours of phototherapy. The infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes. Power calculation based on expected difference in decrease of TSB of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.

Official Title
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Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.

Conditions
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Neonatal Jaundice

Intervention / Treatment
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* Device: Phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for phototherapy with single light Gestational age > 33 weeks Birth weight > 1800 grams Should be treatable in a cradle Exclusion Criteria: Haemolytic disease Indication for double/triple phototherapy or exchange transfusion

Ages Eligible for Study
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Minimum Age: 25 Hours
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Infants are randomised to phototherapy with blue LED's with wavelength of 478 or 459 nm. The decrease of TSB between the groups is compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phototherapy 478 nm<br>The jaundiced neonates receives phototherapy with blue light from above at wavelength 478 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice. | Device: Phototherapy<br>* Phototherapy for 24 hours.<br>|
| Active Comparator: Phototherapy 459 nm<br>The jaundiced neonates receives phototherapy with blue light from above at wavelength 459 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice. | Device: Phototherapy<br>* Phototherapy for 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of total serum bilirubin |  | 24 hours of phototherapy |