Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes

NCT ID: NCT02154165

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

Brief Summary

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The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Though, previous studies used light tubes, today we use light emitting diodes (LED'S).

The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus blue LED's for decreasing total serum bilirubin in neonates with gestational age \> 33 weeks and uncomplicated hyperbilirubinemia.

Detailed Description

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Conditions

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Uncomplicated Neonatal Hyperbilirubinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Blue light wavelenght 460 nm

Group Type ACTIVE_COMPARATOR

Phototherapy

Intervention Type OTHER

The infants were randomized to phototherapy with either blue og turquoise light

Turquoise light wavelength 499 nm

Group Type ACTIVE_COMPARATOR

Phototherapy

Intervention Type OTHER

The infants were randomized to phototherapy with either blue og turquoise light

Interventions

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Phototherapy

The infants were randomized to phototherapy with either blue og turquoise light

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newborns with gestational age \>33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines

Exclusion Criteria

* Haemolytic disease (Rhesus and Kell blood type isoimmunization, spherocytosis)
* Liver disease
Minimum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Helene Nørrelund

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Neonatal department, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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PKV 2013

Identifier Type: -

Identifier Source: org_study_id

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