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

Neonatal Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03183986
• Other study ID #: N-20160071
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2017
• Last updated: June 19, 2017
• Start date: March 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: June 2017
• Source: University of Aarhus
• Contact: Pernille K Vandborg, MD, PhD
• Phone: + 45 26131711
• Email: pervan[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

Device:
• Phototherapy
Phototherapy for 24 hours.

Locations

Country	Name	City	State
Denmark	Neonatal department, Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg Universitetshospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Lamola AA. A Pharmacologic View of Phototherapy. Clin Perinatol. 2016 Jun;43(2):259-76. doi: 10.1016/j.clp.2016.01.004. Epub 2016 Feb 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of total serum bilirubin		24 hours of phototherapy