Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.
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|ClinicalTrials.gov Identifier: NCT03183986|
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Jaundice||Device: Phototherapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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)|
|Official Title:||Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||March 1, 2018|
|Estimated Study Completion Date :||July 1, 2018|
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.
- Decrease of total serum bilirubin [ Time Frame: 24 hours of phototherapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183986
|Contact: Pernille K Vandborg, MD, PhD||+ 45 firstname.lastname@example.org|
|Contact: Mette R Donneborg, MD||+ 45 email@example.com|
|Neonatal department, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Mette Donneborg, MD +45 22406344 firstname.lastname@example.org|
|Contact: Finn Ebbesen, Professor, MD + 45 97663330 email@example.com|
|Principal Investigator: Mette Donneborg, MD|
|Sub-Investigator: Pernille Vandborg, MD, PhD|
|Sub-Investigator: Finn Ebbesen, DmSci|
|Principal Investigator:||Mette Donneborg, MD||Aalborg University Hospital|