Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

Neonatal Hyperbilirubinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04585828
• Other study ID #: 71051
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: September 2022

Study information

• Verified date: September 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of phototherapy	Change in total serum bilirubin	Measurement of bilirubin before phototherapy and after 24 hours