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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03183986
Enrollment
100
Registered
2017-06-12
Start date
2017-03-01
Completion date
2018-07-01
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Jaundice

Brief 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.

Detailed 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.

Interventions

DEVICEPhototherapy

Phototherapy for 24 hours.

Sponsors

Aalborg University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
25 Hours to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Decrease of total serum bilirubin24 hours of phototherapy

Countries

Denmark

Contacts

Primary ContactPernille K Vandborg, MD, PhD
pervan@rm.dk+ 45 26131711
Backup ContactMette R Donneborg, MD
mld@rn.dk+ 45 22406344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026