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

University of Aarhus

Status: Unknown

Conditions: Neonatal Jaundice

Treatments: Device: Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03183986

N-20160071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 25 hours to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Phototherapy 478 nm

Active Comparator group

Description:

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.

Treatment:

Device: Phototherapy

Phototherapy 459 nm

Active Comparator group

Description:

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.

Treatment:

Device: Phototherapy