Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

Study Overview
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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.

Official Title
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Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy for Treatment of Neonatal Hyperbilirubinemia

Conditions
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Neonatal Hyperbilirubinemia

Intervention / Treatment
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* Device: Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon
* Device: Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bili Cocoon<br>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. | Device: Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon<br>* The baby will be treated with Bilicocoon for 24 hours. Decrease of total serum biliurubin will be evalueated hereafter.<br>|
| Active Comparator: Conventional blue light<br>The infants will be treated with blue light from above at 30 Uw/cm2/nm which is the standard treatment. | Device: Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm<br>* The baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Day 1 of phototherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of phototherapy | Change in total serum bilirubin | Measurement of bilirubin before phototherapy and after 24 hours |