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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03183986
Other study ID # N-20160071
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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