Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

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

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.

Study Overview

• Status: Unknown
• Conditions: Neonatal Hyperbilirubinemia
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Conventional blue light; 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; The baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: 71051

Drug and device information, study documents

• 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