Neonatal HyperbilirubinemiaTRABINNCT04246229
Transcutaneous Bilirubinometry and Phototherapy
A study testing Transcutaneous bilirubinometry and Serum bilirubin in people with Neonatal Hyperbilirubinemia, run by Princess Amalia Children's Clinic at 1 site in Netherlands.
Trial summary
A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Read more about this study
- Who is it for?
- Ages 0 days to 2 weeks
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Transcutaneous bilirubinometry and Serum bilirubin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 days to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with indication for phototherapy for treatment of hyperbilirubinemia
Who cannot join
- skinlesions located on the sternum interfering with transcutaneous measurement
- exchange transfusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial
A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia.
Read the detailed description
A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Main outcome measurement is the number of blooddraws for measurement of bilirubin. Secondary outcome measurements are duration of phototherapy and hospitalisation.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Transcutaneous bilirubinometry, Serum bilirubin
- Keywords
- transcutaneous bilirubinometry, phototherapy, neonatal icterus, neonatal jaundice, newborn
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous bilirubinometryDiagnostic test
use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels
Serum bilirubinDiagnostic test
Also called blood draw
use of blood draws to measure serum bilirubin level
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous bilirubinometry | Experimental | in this arm the bilirubin level to monitor the effect of phototherapy will be measured through transcutaneous mbiirubinometry Receives: Diagnostic Test: Transcutaneous bilirubinometry |
| serum bilirubin | Active comparator | In this arm the bilirubin level to monitor the effect of phototherapy wil be measured through measurements of serum bilirubin obtained through blood draws Receives: Diagnostic Test: Serum bilirubin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood draws
number of blood draws from the start of phototherapy for measurement of serum bilirubin
Measured: during hospitalisation with a maximum of 14 days
Secondary outcomes (2)
phototherapy duration
duration of phototherapy in hours
Measured: during hospitalisation with a maximum of 14 days
hospitalisation
duration of hospitalisation in days
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Princess Amalia Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolita Bekhof, Princess Amalia Children's Clinic
- Investigators
- Jolita Bekhof, MD,PhD, Principal investigator, 1971
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246229
- Sponsor's protocol ID
- 202001
- Acronym
- TRABIN
- Status last verified
- Jul 2024
- First submitted
- 26 Jan 2020
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publishing the results the individual participant data will be anonimously available upon request
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04246229
- Acronym / sponsor ID
- TRABIN / 202001
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- transcutaneous bilirubinometry, phototherapy, neonatal icterus, neonatal jaundice, newborn
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Princess Amalia Children's ClinicUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Jan 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 Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia.
Detailed description
A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Main outcome measurement is the number of blooddraws for measurement of bilirubin. Secondary outcome measurements are duration of phototherapy and hospitalisation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcutaneous bilirubinometry | Experimental | Diagnostic Test: Transcutaneous bilirubinometryin this arm the bilirubin level to monitor the effect of phototherapy will be measured through transcutaneous mbiirubinometry |
| serum bilirubin | Active comparator | Diagnostic Test: Serum bilirubinIn this arm the bilirubin level to monitor the effect of phototherapy wil be measured through measurements of serum bilirubin obtained through blood draws |
Who may qualify
- Ages
- 0 days to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates with indication for phototherapy for treatment of hyperbilirubinemia
Key exclusion criteria (2 listed)
- skinlesions located on the sternum interfering with transcutaneous measurement
- exchange transfusion
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 |
|---|---|---|
| Transcutaneous bilirubinometryuse of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels | Diagnostic test | transcutaneous bilirubinometry |
| Serum bilirubinAlso: blood drawuse of blood draws to measure serum bilirubin level | Diagnostic test | serum bilirubin |
Primary outcome
blood draws
Time frame: during hospitalisation with a maximum of 14 days
number of blood draws from the start of phototherapy for measurement of serum bilirubin
2 secondary outcomes
phototherapy duration
Time frame: during hospitalisation with a maximum of 14 days
hospitalisation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: Yes. After publishing the results the individual participant data will be anonimously available upon request
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
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Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
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Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
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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.
Jolita Bekhof, MD,PhD principal investigator
1971
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous bilirubinometry and Serum bilirubin in people with Neonatal Hyperbilirubinemia, run by Princess Amalia Children's Clinic at 1 site in Netherlands.
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 1 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: opening soon, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jolita Bekhof, MD, PhD (+31384245050, j.bekhof@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood draws (time frame: during hospitalisation with a maximum of 14 days). 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 2 Aug 2024.