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

Not Applicable

• Conditions: Neonatal Jaundice
• Interventions: Device: Phototherapy

• Registration Number: NCT03183986
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20
• Primary Completion: 2018-03-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Indication for phototherapy with single light
• Gestational age > 33 weeks
• Birth weight > 1800 grams
• Should be treatable in a cradle

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Exclusion Criteria

• Haemolytic disease
• Indication for double/triple phototherapy or exchange transfusion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phototherapy 478 nm	Phototherapy	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.
Phototherapy 459 nm	Phototherapy	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.

Primary Outcome Measures

Name	Time	Method
Decrease of total serum bilirubin	24 hours of phototherapy

Trial Locations

Locations (1)

Neonatal department, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark