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Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

NCT04585828 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-10-22

No results posted yet for this study

Summary

A randomized study of phototherapy for neonatal hyperbilirubinemia. The intervention group is treated with a double pad fiber optic device and the control group with conventional blue ligt phototherapy from above. Both treatments are well known and used. The primary outcome is to explore the parents experience with the two different treatment modalities by questionnaires.

Conditions

  • Neonatal Hyperbilirubinemia

Interventions

DEVICE

Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon

The baby will be treated with Bilicocoon for 24 hours. Decrease of total serum biliurubin will be evalueated hereafter.

DEVICE

Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm

The baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2022-09-30
Completion
2022-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04585828 on ClinicalTrials.gov