Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

NCT04585828 | Unknown DMC

• 1 other identifier: 71051
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of phototherapy

  Measurement of bilirubin before phototherapy and after 24 hours

Study Arms (2)

Bili Cocoon

EXPERIMENTAL

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

Conventional blue light

ACTIVE COMPARATOR

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

Interventions

Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon DEVICE

The baby will be treated with Bilicocoon for 24 hours. Decrease of total serum biliurubin will be evalueated hereafter.

Bili Cocoon

Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm DEVICE

The baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter.

Conventional blue light

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 14, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-09