Newborn JaundiceBili-PrediX1NCT05121311
Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm
An observational study of Newborn Jaundice, run by NeoPredix AG at 2 sites in Germany.
Trial summary
Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia. As the peak is often one or two days after discharge from hospital a more precise predication than the actual one is desirable to avoid needlessly follow-ups. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Newborn Jaundice
- What is being tested?
- NeoprediX B1 algorithm
- How many people
- 455 participants
- Where
- 2 sitesGermany
- Study dates
- 9 Aug 2021to 31 Jan 2022
- Phase
- Observational
- 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 Up to 72 hours
- All sexes
- Child
Study population: Newborn infants
Who may be able to join
- Newborn infant
- gestational age at birth ≥ 34+0/7 weeks
Who cannot join
- Birth weight < 1500g
- Gestational age at birth > 42+6/7 weeks
- Genetically defined syndrome
- Severe congenital malformation adversely affecting life expectancy or admission for a priori planned palliative care
- Parents not fluent in German
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
KUNO Kinderklinik St. Hedwig
Regensburg, 93049
University Children's Hospital
Tübingen, 72076
About this study
Official title: Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm - Prospective Observational Study -
Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia. As the peak is often one or two days after discharge from hospital a more precise predication than the actual one is desirable to avoid needlessly follow-ups. The precision of an algorithm to predict bilirubin values 24-48h into the future is evaluated in this study.
Read the detailed description
Neonatal jaundice is common and mostly transient without need for intervention. To identify infants at risk of bilirubin toxicity, bilirubin is measured several times after birth and before discharge home. As the peak bilirubin concentrations are reached at days 4-6 after birth, and most infants are discharged home around 48 hours after birth, parents are often asked to return to hospital one or two days after discharge with their newborn baby to have the bilirubin value checked in order to prevent that hyperbilirubinemia requiring treatment is not missed. A precise prediction of the course of bilirubin values based on the measurements done during the initial hospital stay after birth would be desirable to avoid unnecessary follow ups (both for the families and the health care system).
This study aims to evaluate the precision of the NeoprediX B1 algorithm. This algorithm predicts bilirubin values 24-48h into the future based on preceding values and some clinical variables. Five different scenarios will be explored, differing in the type, number and timepoints of measurements used for the prediction as well as the timepoint that is to be predicted.
- Conditions
- Newborn Jaundice
- Being tested
- NeoprediX B1 algorithm
- Keywords
- newborn jaundice, Hyperbilirubinaemia
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoprediX B1 algorithmDiagnostic test
Re-assessement of bilirubin measurements done according to standard of care of the participating center by the NeoprediX B1 algorithm
| Study group | Role | What they receive |
|---|---|---|
| Newborns under bilirubin monitoring | Bilirubin monitoring according to standard of care of the participating center Receives: Diagnostic Test: NeoprediX B1 algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision of predicted bilirubin value
Precision of the bilirubin value calculated by the NeoprediX B1 algorithm compared to the value measured by the center
Measured: 8 hours to 144 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start9 Aug 2021
- Primary completion30 Nov 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn JaundiceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoPredix AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Pediatric Clinical Studies (CPCS)
- Responsible party
- Sponsor
- Investigators
- Axel Franz, Prof., Principal investigator, University Children's Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121311
- Sponsor's protocol ID
- 507/2021B02
- Acronym
- Bili-PrediX1
- Status last verified
- May 2022
- First submitted
- 18 Aug 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neonatal Hyperbilirubinemia by NeoprediX B.1 Algorithm - Prospective Observational Study -
- ClinicalTrials.gov ID
- NCT05121311
- Acronym / sponsor ID
- Bili-PrediX1 / 507/2021B02
- Conditions
- Newborn Jaundice
- Keywords
- newborn jaundice, Hyperbilirubinaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- NeoPredix AGIndustry (pharma, biotech, devices)
- Collaborators
- Center for Pediatric Clinical Studies (CPCS)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 16 Nov 2021 (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.
Due to actual standard of neonatal care bilirubin is monitored in neonates several times after birth to avoid hyperbilirubinemia. As the peak is often one or two days after discharge from hospital a more precise predication than the actual one is desirable to avoid needlessly follow-ups. The precision of an algorithm to predict bilirubin values 24-48h into the future is evaluated in this study.
Detailed description
Neonatal jaundice is common and mostly transient without need for intervention. To identify infants at risk of bilirubin toxicity, bilirubin is measured several times after birth and before discharge home. As the peak bilirubin concentrations are reached at days 4-6 after birth, and most infants are discharged home around 48 hours after birth, parents are often asked to return to hospital one or two days after discharge with their newborn baby to have the bilirubin value checked in order to prevent that hyperbilirubinemia requiring treatment is not missed. A precise prediction of the course of bilirubin values based on the measurements done during the initial hospital stay after birth would be desirable to avoid unnecessary follow ups (both for the families and the health care system).
This study aims to evaluate the precision of the NeoprediX B1 algorithm. This algorithm predicts bilirubin values 24-48h into the future based on preceding values and some clinical variables. Five different scenarios will be explored, differing in the type, number and timepoints of measurements used for the prediction as well as the timepoint that is to be predicted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns under bilirubin monitoring | – | Diagnostic Test: NeoprediX B1 algorithmBilirubin monitoring according to standard of care of the participating center |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Age groups
- Child
- Study population
- Newborn infants
Key inclusion criteria (2 listed)
- Newborn infant
- gestational age at birth ≥ 34+0/7 weeks
Key exclusion criteria (5 listed)
- Birth weight < 1500g
- Gestational age at birth > 42+6/7 weeks
- Genetically defined syndrome
- Severe congenital malformation adversely affecting life expectancy or admission for a priori planned palliative care
- Parents not fluent in German
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 |
|---|---|---|
| NeoprediX B1 algorithmRe-assessement of bilirubin measurements done according to standard of care of the participating center by the NeoprediX B1 algorithm | Diagnostic test | Newborns under bilirubin monitoring |
Primary outcome
Precision of predicted bilirubin value
Time frame: 8 hours to 144 hours after birth
Precision of the bilirubin value calculated by the NeoprediX B1 algorithm compared to the value measured by the center
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: No
Related trials for Newborn Jaundice
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Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
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Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In 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. This study is not recruiting at the moment.
Axel Franz, Prof. principal investigator
University Children's Hospital Tübingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Jaundice, run by NeoPredix AG at 2 sites in Germany.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Precision of predicted bilirubin value (time frame: 8 hours to 144 hours after birth). 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 3 May 2022.