Neonatal HyperbilirubinemiaNCT04585828
Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy
A study testing Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon and Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm in people with Neonatal Hyperbilirubinemia, run by University of Aarhus.
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. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon and Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Hemolysis due to isoimmunization
- Very high or rapidly rising total serum bilirubin
About this study
Official title: 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.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon, Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili CocoonDevice
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/nmDevice
The baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 of phototherapy
Secondary outcomes (1)
Effect of phototherapy
Change in total serum bilirubin
Measured: Measurement of bilirubin before phototherapy and after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585828
- Sponsor's protocol ID
- 71051
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy for Treatment of Neonatal Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT04585828
- Acronym / sponsor ID
- 71051
- Conditions
- Neonatal Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bili Cocoon | Experimental | Device: Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili CocoonThe 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. |
| Conventional blue light | Active comparator | Device: Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nmThe infants will be treated with blue light from above at 30 Uw/cm2/nm which is the standard treatment. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Hemolysis due to isoimmunization
- Very high or rapidly rising total serum bilirubin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili CocoonThe baby will be treated with Bilicocoon for 24 hours. Decrease of total serum biliurubin will be evalueated hereafter. | Device | Bili Cocoon |
| Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nmThe baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter. | Device | Conventional blue light |
Primary outcome
Questionnaire on the parents experience with the phototherapy treatment
Time frame: 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)
1 secondary outcome
Effect of phototherapy
Time frame: Measurement of bilirubin before phototherapy and after 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon and Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm in people with Neonatal Hyperbilirubinemia, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on the parents experience with the phototherapy treatment (time frame: Day 1 of phototherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.