Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

NCT ID: NCT04585828

Last Updated: 2020-10-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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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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Bili Cocoon

The infants will be treated with phototherapy using a double sided fiber optic pad called Bili Cocoon with an irradiance of 30 uW/cm2/nm from both sides.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Conventional blue light

The infants will be treated with blue light from above at 30 Uw/cm2/nm which is the standard treatment.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Neonatal icterus and total serum bilirubin above threshold for phototherapy.
* Gestational age ≥ 33 weeks
* Birth weight ≥ 1800 gr
* Postnatal age \> 24 hours and \< 2 weeks

Exclusion Criteria

* Hemolysis due to isoimmunization
* Very high or rapidly rising total serum bilirubin
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

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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Responsibility Role SPONSOR

Other Identifiers

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71051

Identifier Type: -

Identifier Source: org_study_id

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