Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

Not Applicable

• Conditions: Neonatal Hyperbilirubinemia
• Interventions: Device: Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm; Device: Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon

• Registration Number: NCT04585828
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-21
• Study Start: 2020-10
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• Hemolysis due to isoimmunization
• Very high or rapidly rising total serum bilirubin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional blue light	Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm	The infants will be treated with blue light from above at 30 Uw/cm2/nm which is the standard treatment.
Bili Cocoon	Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using 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.

Primary Outcome Measures

Name	Time	Method
Questionnaire on the parents experience with the phototherapy treatment	Day 1 of phototherapy	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

Name	Time	Method
Effect of phototherapy	Measurement of bilirubin before phototherapy and after 24 hours	Change in total serum bilirubin