Birth AsphyxiaAAMBI2NCT04714502
Asphyxia Associated Metabolite Biomarker Investigation 2
An observational study of Birth Asphyxia, run by InfanDx AG at 4 sites in Turkey (Türkiye).
Trial summary
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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 22 to 48 months
- Conditions the study is for
- Birth Asphyxia
- How many people
- 144 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 2 Jul 2019to 31 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 AAMBI 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 or because they had been enrolled in AAMBI as healthy controls (with adaptation disorder only).
Who may be able to join
- Infants previously enrolled in the AAMBI1 study
Who cannot join
- Missing valid written informed parental consent
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Turkey Cukurova University
Adana, 01330
University of Firat
Elâzığ, 23110
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 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 AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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
Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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
- Birth Asphyxia
- Keywords
- biomarkers, asphyxia, Hypoxic ischemic encephalopathy
- Medical subject headings
- Asphyxia Neonatorum, Asphyxia, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants enrolled in AAMBI1 | Not described |
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 start2 Jul 2019
- Primary completion31 Oct 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth AsphyxiaStudies 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- InfanDx AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cukurova University, University Children's Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Ron Meyer, Study director, InfanDx AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714502
- Sponsor's protocol ID
- AAMBI2
- Acronym
- AAMBI2
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 19 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 19 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 Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test
- ClinicalTrials.gov ID
- NCT04714502
- Acronym / sponsor ID
- AAMBI2 / AAMBI2
- Conditions
- Birth Asphyxia
- Keywords
- biomarkers, asphyxia, Hypoxic ischemic encephalopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- InfanDx AGIndustry (pharma, biotech, devices)
- Collaborators
- Cukurova University, University Children's Hospital Tuebingen
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 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 AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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
Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants enrolled in AAMBI1 | – | – |
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 AAMBI 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 or because they had been enrolled in AAMBI as healthy controls (with adaptation disorder only).
Key inclusion criteria (1 listed)
- Infants previously enrolled in the AAMBI1 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 19 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Birth Asphyxia
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
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 Birth Asphyxia, run by InfanDx AG 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 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 19 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?
Results are not available in the source record.
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?
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 19 Jan 2021.