Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
|Official Title:||Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.|
- Decrease of total serum bilirubin [ Time Frame: 24 hours of phototherapy ]
|Actual Study Start Date:||March 1, 2017|
|Estimated Study Completion Date:||July 1, 2018|
|Estimated Primary Completion Date:||March 1, 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Phototherapy 478 nm
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 for 24 hours.
Active Comparator: Phototherapy 459 nm
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.
Phototherapy for 24 hours.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03183986
|Contact: Pernille K Vandborg, MD, PhD||+ 45 email@example.com|
|Contact: Mette R Donneborg, MD||+ 45 firstname.lastname@example.org|
|Neonatal department, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Mette Donneborg, MD +45 22406344 email@example.com|
|Contact: Finn Ebbesen, Professor, MD + 45 97663330 firstname.lastname@example.org|
|Principal Investigator: Mette Donneborg, MD|
|Sub-Investigator: Pernille Vandborg, MD, PhD|
|Sub-Investigator: Finn Ebbesen, DmSci|
|Principal Investigator:||Mette Donneborg, MD||Aalborg Universitetshospital|