Asphyxia NeonatorumBANON2NCT04714775
Biomarkers And Neurological Outcome in Neonates 2
An observational study of Asphyxia Neonatorum, run by InfanDx AG at 13 sites in 2 countries.
Trial summary
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their ability to diagnose the severity of neonatal asphyxia. Read more about this study
- Who is it for?
- Ages 22 to 48 months
- Conditions the study is for
- Asphyxia Neonatorum
- How many people
- 500 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 5 Feb 2019to Dec 2021
- 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 22 to 48 months
- All sexes
- No healthy volunteers
- Child
Study population: Children, who had been enrolled in the BANON study immediately after birth because they had been suspected to be at risk for perinatal brain injury (hypoxic-ischemic encephalopathy, HIE) and/or evaluated for hypothermia therapy.
Who may be able to join
- Infants previously enrolled in BANON study
Who cannot join
- Missing valid written informed parental consent
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Germany11 sites, 11 recruiting
- Recruiting
Städtisches Krankenhaus Aschaffenburg
Aschaffenburg, 63739
Christian Wieg, Dr. med., christian.wieg@klinikum-ab-alz.de
Christian Wieg, Dr. med.
- Recruiting
Universitätsklinikum Carl Gustav Carus, Neonatologie
Dresden, 01307
Stefan Winkler, Dr. med., stefan.winkler@uniklinikum-dresden.de
Stefan Winkler, Dr. med.
- Recruiting
Uniklinik Essen
Essen, 45147
Ursula Felderhoff, Prof., ursula.felderhoff@uk-essen.de
Ursula Felderhoff, Prof.
- Recruiting
Marienkrankenhaus
Hamburg, 22149
Lutz Koch, Prof., l.koch@KKH-Wilhelmstift.de
Lutz Koch, Prof.
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
Johannes Pöschl, Prof., johannes.poeschl@med.uni-heidelberg.de
Johannes Pöschl, Prof.
- Recruiting
Städtisches Klinikum Karlsruhe, Klinik für Kinder- und Jugendmedizin
Karlsruhe, 76133
Joachim Kühr, Prof., Joachim.Kuehr@klinikum-karlsruhe.de
Joachim Kühr, Prof.
- Recruiting
Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden,
München, 80638
Jochen Peters, Prof., J.Peters@dritter-orden.de
Jochen Peters, Prof.
- Recruiting
Universitäts Kinderkrankenhaus und Perinatal Zentrum
München, 81377
Andreas Flemmer, Prof., andreas.flemmer@med.uni-muenchen.de
Andreas Flemmer, Prof.
- Recruiting
Kinderklinik Dritter Orden
Passau, 94032
Matthias Keller, Prof., matthias.keller@kinderklinik-passau.de
Matthias Keller, Prof.
- Recruiting
Klinik St. Hedwig
Regensburg, 93049
Jochen Kittel, Dr. med., Jochen.Kittel@barmherzige-regensburg.de
Jochen Kittel, Dr. med.
- Recruiting
Universitätsklinikum Tübingen, Universiätsklinik für Kinder- u. Jugendmedizin
Tübingen, 72076
Axel Franz, Prof., axel.franz@med.uni-tuebingen.de
Axel Franz, Prof.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Cukurova University Hospital
Adana, 01330
Hacer Yapicioglu-Yildizdas, Prof.
Hacer Yapicioglu-Yildizdas, Prof.
- Recruiting
University of Firat, Department of Pediatrics
Elâzığ, 23040
Erdal Taskin, Prof.
Erdal Taskin, Prof.
About this study
Official title: Validation of Biomarkers of Adverse Neurologic Outcome in Newborns at Risk for Perinatal Brain Injury - Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.
Read the detailed description
Follow-Up on neuro-developmental status of Study participants of BANON1. BANON1 (ClinicalTrials.gov ID: NCT03357250): The aim of the study is to validate the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. The population at risk is defined as term and late preterm (>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.
- Conditions
- Asphyxia Neonatorum
- Keywords
- Biomarkers, Asphyxia, Hypoxic ischemic encephalopathy
- Medical subject headings
- Asphyxia Neonatorum, Asphyxia, Hypoxia-Ischemia, Brain
What is being measured
The primary outcome is the main question the study is designed to answer.
participants with normal neuro-developmental status
all infants with normal neuro-developmental status
Measured: up to 42 month age
participants with potentially abnormal neuro-developmental status
All infants who do not fulfill outcomes 1, 3 or 4
Measured: up to 42 month age
participants with abnormal neuro-developmental status - HIE
Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury
Measured: up to 42 month age
participants with abnormal neuro-developmental status - non-HIE
Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury
Measured: up to 42 month age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start5 Feb 2019
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asphyxia NeonatorumStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InfanDx AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Ron Meyer, Study director, InfanDx AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714775
- Sponsor's protocol ID
- BANON2
- Acronym
- BANON2
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Biomarkers of Adverse Neurologic Outcome in Newborns at Risk for Perinatal Brain Injury - Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test
- ClinicalTrials.gov ID
- NCT04714775
- Acronym / sponsor ID
- BANON2 / BANON2
- Conditions
- Asphyxia Neonatorum
- Keywords
- Biomarkers, Asphyxia, Hypoxic ischemic encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- InfanDx AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Tuebingen
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Jan 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.
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.
Detailed description
Follow-Up on neuro-developmental status of Study participants of BANON1. BANON1 (ClinicalTrials.gov ID: NCT03357250): The aim of the study is to validate the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. The population at risk is defined as term and late preterm (>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children, who had been enrolled in the BANON study immediately after birth because they had been suspected to be at risk for perinatal brain injury (hypoxic-ischemic encephalopathy, HIE) and/or evaluated for hypothermia therapy.
Key inclusion criteria (1 listed)
- Infants previously enrolled in BANON study
Key exclusion criteria (1 listed)
- Missing valid written informed parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
participants with normal neuro-developmental status
Time frame: up to 42 month age
all infants with normal neuro-developmental status
participants with potentially abnormal neuro-developmental status
Time frame: up to 42 month age
All infants who do not fulfill outcomes 1, 3 or 4
participants with abnormal neuro-developmental status - HIE
Time frame: up to 42 month age
Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury
participants with abnormal neuro-developmental status - non-HIE
Time frame: up to 42 month age
Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Related trials for Asphyxia Neonatorum
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
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.
Ron Meyer study director
InfanDx AG
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asphyxia Neonatorum, run by InfanDx AG at 13 sites in 2 countries.
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 1 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 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ron Meyer (+49 172 266 5552, ron.meyer@infandx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
participants with normal neuro-developmental status (time frame: up to 42 month age). The study lists 4 primary outcomes in all. 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 20 Jan 2021.