NCT03183986

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 25 Hours – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Jaundice

Interventions

Type	Name	Description
DEVICE	Phototherapy	Phototherapy for 24 hours.

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-03-01
• Completion: 2018-07-01
• First posted: 2017-06-12
• Last updated: 2017-06-20

Locations

1 site across 1 country: Denmark