Asphyxia NeonatorumAAMBINCT03354208
Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
An observational study of Asphyxia Neonatorum, run by Life Science Inkubator at 4 sites in Turkey (Türkiye).
Trial summary
Verification 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. Read more about this study
- Who is it for?
- Ages 0 to 2 hoursHealthy volunteers can take part
- Conditions the study is for
- Asphyxia Neonatorum
- What is being tested?
- blood sampling
- How many people
- 155 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- Oct 2016to 27 Dec 2017
- 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 2 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants at risk for perinatal hypoxic-ischemic brain injury
Who may be able to join
- Group 1: inclusion criteria fulfilled for hypothermia treatment Group 2: Infants with suspected perinatal brain injury due to one of the followings
- Perinatal hypoxia-ischemia (defined as a perinatal acidosis indicated by a pH≤7.10 or a base excess ≤-12mmol/l in umbilical cord blood or early postnatal blood collected at <90min of age (outborn patients)
- 5min APGAR-score ≤ 5
- Need for resuscitation after birth for >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube, or cardiac compressions Group 3: UApH >7,25, and adaptation disorder of the newborn and need of postnatal clinical surveillance
Who cannot join
- gestational age < 36 weeks
- age at time of screening >2,5h
- congenital malformation
- missing or invalid informed parental consent
- unsuccessful resuscitation
- infant considered not-viable
- decision for palliative care only
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Cukurova University
Adana, 01330
University of Firat
Elâzığ
Özel Güngören Hastanesi
Istanbul, 34164
Mersin University School of Medicine
Mersin, 33343
About this study
Official title: Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test
Verification 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.
Read the detailed description
The aim of the study is to verify 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.
- Conditions
- Asphyxia Neonatorum
- Being tested
- blood sampling
- Keywords
- biomarkers
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
small volume blood sampling, according to local laws, is not categorized as intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy Receives: Other: blood sampling | |
| Group 2 | patients with suspected HIE, non-confirmed Receives: Other: blood sampling | |
| Group 3 | healthy, retrospectively classified as such Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
abnormal short-term outcome (NE)
All patients are classified as abnormal short-term outcome (neonatal encephalopathy, NE) or normal short term outcome (no encephalopathy) by using clinical data, particularly Thompson score. For Group 1 and group 2 patients outcome classification will be additionally confirmed by using cranial ultrasound or MRI (including severe ischemia based on DWI or thalamic or cerebellar bleeding or arterial infarction or IVH>2° according to Papile, thalamic ischemia or severe cerebral edema) or seizure activity or burst suppression on aEEG or persistingly abnormal aEEG background pattern after complete rewarming.
Bloodplasma samples will be analysed by a metabolomics approach using the p180-kit (Biocrates, Innsbruck, Austria). Metabolite concentrations or combinations thereof will be compared to the outcome described above in order to identify the most suitable metabolites to be used for early detection of NE in newborn infants.
Measured: 14 days for clinical diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study startOct 2016
- Primary completion27 Dec 2017
- Study completion27 Dec 2017
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
- 155 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Life Science Inkubator
- Sponsor type
- University, hospital or other
- Collaborators
- Cukurova University, University Children's Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Ron Meyer, Study director, Life Science Inkubator Betriebs GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354208
- Sponsor's protocol ID
- AAMBI I
- Acronym
- AAMBI
- Status last verified
- Jan 2021
- First submitted
- 22 Sep 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
- Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test
- ClinicalTrials.gov ID
- NCT03354208
- Acronym / sponsor ID
- AAMBI / AAMBI I
- Conditions
- Asphyxia Neonatorum
- Keywords
- biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Life Science InkubatorUniversity, hospital or other
- Collaborators
- Cukurova University, University Children's Hospital Tuebingen
- Study start
- Oct 2016 (actual)
- Primary completion
- 27 Dec 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 27 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.
Verification 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.
Detailed description
The aim of the study is to verify 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: blood samplingpatients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy |
| Group 2 | – | Other: blood samplingpatients with suspected HIE, non-confirmed |
| Group 3 | – | Other: blood samplinghealthy, retrospectively classified as such |
Who may qualify
- Ages
- 0 to 2 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants at risk for perinatal hypoxic-ischemic brain injury
Key inclusion criteria (4 listed)
- Group 1: inclusion criteria fulfilled for hypothermia treatment Group 2: Infants with suspected perinatal brain injury due to one of the followings
- Perinatal hypoxia-ischemia (defined as a perinatal acidosis indicated by a pH≤7.10 or a base excess ≤-12mmol/l in umbilical cord blood or early postnatal blood collected at <90min of age (outborn patients)
- 5min APGAR-score ≤ 5
- Need for resuscitation after birth for >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube, or cardiac compressions Group 3: UApH >7,25, and adaptation disorder of the newborn and need of postnatal clinical surveillance
Key exclusion criteria (7 listed)
- gestational age < 36 weeks
- age at time of screening >2,5h
- congenital malformation
- missing or invalid informed parental consent
- unsuccessful resuscitation
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 |
|---|---|---|
| blood samplingsmall volume blood sampling, according to local laws, is not categorized as intervention (observational study) | Other | Group 1, Group 2, Group 3 |
Primary outcome
abnormal short-term outcome (NE)
Time frame: 14 days for clinical diagnosis
All patients are classified as abnormal short-term outcome (neonatal encephalopathy, NE) or normal short term outcome (no encephalopathy) by using clinical data, particularly Thompson score. For Group 1 and group 2 patients outcome classification will be additionally confirmed by using cranial ultrasound or MRI (including severe ischemia based on DWI or thalamic or cerebellar bleeding or arterial infarction or IVH>2° according to Papile, thalamic ischemia or severe cerebral edema) or seizure activity or burst suppression on aEEG or persistingly abnormal aEEG background pattern after complete rewarming. Bloodplasma samples will be analysed by a metabolomics approach using the p180-kit (Biocrates, Innsbruck, Austria). Metabolite concentrations or combinations thereof will be compared to the outcome described above in order to identify the most suitable metabolites to be used for early detection of NE in newborn infants.
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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Asphyxia Neonatorum, Fetal Hypoxia
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
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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.
Ron Meyer study director
Life Science Inkubator Betriebs GmbH & Co. KG
4 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 4 sites in Turkey (Türkiye).
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 7 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 4 sites in 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?
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?
abnormal short-term outcome (NE) (time frame: 14 days for clinical diagnosis). 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.