Asphyxia NeonatorumNCT03357250
Biomarkers And Neurological Outcome in Neonates (BANON)
An observational study of Asphyxia Neonatorum, run by Life Science Inkubator at 11 sites in Germany.
Trial summary
Validation of biomarkers 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 more about this study
- Who is it for?
- Ages 0 to 90 minutesHealthy volunteers can take part
- Conditions the study is for
- Asphyxia Neonatorum
- How many people
- 553 participants
- Where
- 11 sitesGermany
- Study dates
- Sep 2016to Jun 2019
- How long will I take part?
- 14 Days
- 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 0 to 90 minutes
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants at risk for perinatal hypoxic-ischemic brain injury
Who may be able to join
- Need for resuscitation after birth: For >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only CPAP), or cardiac compressions
- 5 min APGAR-score ≤ 5.
- Perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a pH≤7.1 in arterial umbilical cord blood or early postnatal blood collected at <30min of age
- Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at <30min of age.
Who cannot join
- Age >1.5h
- gestational age < 36 weeks
- birth weight <2000g
- congenital malformation
- missing valid written informed parental consent
- unsuccessful resuscitation
- infant considered not-viable
- decision for palliative care only
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Abt. Neonatologie und Päd. Intensivmedizin Klinikum
Aschaffenburg, 63739
Neonatologie Universitätsklinikum
Dresden, 01307
Universitätsklinikum Essen Klinik für Kinderheilkunde I Neonatologie
Essen, 45147
Marienkrankenhaus im Wilhelmstift
Hamburg, 22087
Universitätsklinikum Heidelberg Neonatologie
Heidelberg, 69120
Klinik für Kinder- und Jugendmedizin
Karlsruhe, 76133
Klinik für Kinder- und Jugendmedizin, Klinikum Dritter Orden
München, 80638
Haunersches Kinderspital am Perinatalzentrum Grosshadern
München, 81377
Kinderklinik Dritter Orden
Passau, 94032
Klinik St. Hedwig Neonatologie
Regensburg, 93049
Klinik für Kinder und Jugendmedizin
Tübingen, 72070
About this study
Official title: Validation of Biomarkers of Adverse Neurologic Outcome in Newborns Who Required Resuscitation or Are Suspected to be at Risk for Perinatal Brain Injury and Long-term Adverse Neurological Outcome A Prospective Multicenter Observational Study for Development of a Diagnostic Test
Validation of biomarkers 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
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
- Medical subject headings
- Asphyxia Neonatorum
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of diagnostic algorithm
The best combinations of biomarkers from the preliminary study will be used and sensitivity and specificity as well as positive and negative likelihood ratios and their 95%-confidence limits will be calculated.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study startSep 2016
- Primary completionJun 2019
- Study completionJun 2019
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
- 553 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Life Science Inkubator
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357250
- Sponsor's protocol ID
- BANON I
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2017
- Last updated
- 12 Jan 2021
- 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 12 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 Who Required Resuscitation or Are Suspected to be at Risk for Perinatal Brain Injury and Long-term Adverse Neurological Outcome A Prospective Multicenter Observational Study for Development of a Diagnostic Test
- ClinicalTrials.gov ID
- NCT03357250
- Acronym / sponsor ID
- BANON I
- Conditions
- Asphyxia Neonatorum
- Keywords
- biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- Life Science InkubatorUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 29 Nov 2017 (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.
Validation of biomarkers 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
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
- Target follow-up
- 14 Days
Who may qualify
- Ages
- 0 to 90 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants at risk for perinatal hypoxic-ischemic brain injury
Key inclusion criteria (4 listed)
- Need for resuscitation after birth: For >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only CPAP), or cardiac compressions
- 5 min APGAR-score ≤ 5.
- Perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a pH≤7.1 in arterial umbilical cord blood or early postnatal blood collected at <30min of age
- Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at <30min of age.
Key exclusion criteria (8 listed)
- Age >1.5h
- gestational age < 36 weeks
- birth weight <2000g
- congenital malformation
- 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
Validation of diagnostic algorithm
Time frame: 10 days
The best combinations of biomarkers from the preliminary study will be used and sensitivity and specificity as well as positive and negative likelihood ratios and their 95%-confidence limits will be calculated.
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 12 Jan 2021.
- Individual participant dataSharing planned: No
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asphyxia Neonatorum, run by Life Science Inkubator at 11 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 4 inclusion and 8 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 12 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 11 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?
Validation of diagnostic algorithm (time frame: 10 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 12 Jan 2021.