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Asphyxia Associated Metabolite Biomarker Investigation 2 (AAMBI2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04714502
Recruitment Status : Active, not recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Collaborators:
Cukurova University
University Children's Hospital Tuebingen
Information provided by (Responsible Party):
InfanDx AG

Brief 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.

Condition or disease
Birth Asphyxia

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.

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Study Type : Observational
Actual Enrollment : 144 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 2, 2019
Actual Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Infants enrolled in AAMBI1



Primary Outcome Measures :
  1. Participants with normal neuro-developmental status [ Time Frame: up to 42 month age ]
    All infants with normal neuro-developmental status

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • Infants previously enrolled in the AAMBI1 study

Exclusion Criteria:

  • Missing valid written informed parental consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714502


Locations
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Turkey
Turkey Cukurova University
Adana, Turkey, 01330
University of Firat
Elazığ, Turkey, 23110
Özel Güngören Hastanesi
Istanbul, Turkey, 34164
Mersin University School of Medicine
Mersin, Turkey, 33343
Sponsors and Collaborators
InfanDx AG
Cukurova University
University Children's Hospital Tuebingen
Investigators
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Study Director: Ron Meyer InfanDx AG
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Responsible Party: InfanDx AG
ClinicalTrials.gov Identifier: NCT04714502    
Other Study ID Numbers: AAMBI2
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by InfanDx AG:
biomarkers
asphyxia
Hypoxic ischemic encephalopathy
Additional relevant MeSH terms:
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Hypoxia-Ischemia, Brain
Asphyxia Neonatorum
Asphyxia
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Hypoxia
Signs and Symptoms, Respiratory
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases