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Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

Primary Purpose

Neonatal Hyperbilirubinemia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon
Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Hyperbilirubinemia

Eligibility Criteria

1 Day - 14 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bili Cocoon

    Conventional blue light

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Questionnaire on the parents experience with the phototherapy treatment
    Parents experience of phototherapy. Questions at time of beginning phototherapy (1): "What did you feel at the time your baby started treatment with phototherapy?" Questions after phototherapy (2): "What did you experience with your baby during the time of phototherapy?" The parents answer on a scale from "I agree, I partly agree, N/A, I partly disagreee, I disagree" Examples of questions: "I felt well informed about the indication and use of phototherapy" (Answer: I agree, partly agree, disagreee etc,) "I was difficult to breastfeed while my baby was on phototherapy" (Answer as above described)

    Secondary Outcome Measures

    Effect of phototherapy
    Change in total serum bilirubin

    Full Information

    First Posted
    September 21, 2020
    Last Updated
    October 19, 2020
    Sponsor
    University of Aarhus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04585828
    Brief Title
    Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy
    Official Title
    Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy for Treatment of Neonatal Hyperbilirubinemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Hyperbilirubinemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bili Cocoon
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conventional blue light
    Arm Type
    Active Comparator
    Arm Description
    The infants will be treated with blue light from above at 30 Uw/cm2/nm which is the standard treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon
    Intervention Description
    The baby will be treated with Bilicocoon for 24 hours. Decrease of total serum biliurubin will be evalueated hereafter.
    Intervention Type
    Device
    Intervention Name(s)
    Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm
    Intervention Description
    The baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter.
    Primary Outcome Measure Information:
    Title
    Questionnaire on the parents experience with the phototherapy treatment
    Description
    Parents experience of phototherapy. Questions at time of beginning phototherapy (1): "What did you feel at the time your baby started treatment with phototherapy?" Questions after phototherapy (2): "What did you experience with your baby during the time of phototherapy?" The parents answer on a scale from "I agree, I partly agree, N/A, I partly disagreee, I disagree" Examples of questions: "I felt well informed about the indication and use of phototherapy" (Answer: I agree, partly agree, disagreee etc,) "I was difficult to breastfeed while my baby was on phototherapy" (Answer as above described)
    Time Frame
    Day 1 of phototherapy
    Secondary Outcome Measure Information:
    Title
    Effect of phototherapy
    Description
    Change in total serum bilirubin
    Time Frame
    Measurement of bilirubin before phototherapy and after 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    14 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

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