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NCT04714502 Clinical Trial

Asphyxia Associated Metabolite Biomarker Investigation 2

Birth Asphyxia Clinical Trial

— AAMBI2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04714502
Other study ID # AAMBI2
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2, 2019
Est. completion date December 31, 2021

Study information
Verified date January 2021
Source InfanDx AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 144
Est. completion date December 31, 2021
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 22 Months to 48 Months
Eligibility Inclusion Criteria: - Infants previously enrolled in the AAMBI1 study Exclusion Criteria: - Missing valid written informed parental consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Turkey Cukurova University Adana
Turkey University of Firat Elazig
Turkey Özel Güngören Hastanesi Istanbul
Turkey Mersin University School of Medicine Mersin

Sponsors (3)
Lead Sponsor Collaborator
InfanDx AG Cukurova University, University Children's Hospital Tuebingen

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Participants with normal neuro-developmental status All infants with normal neuro-developmental status up to 42 month age
Primary Participants with potentially abnormal neuro-developmental status All infants who do not fulfill outcomes 1, 3 or 4 up to 42 month age
Primary Participants with abnormal neuro-developmental status - HIE Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury up to 42 month age
Primary Participants with abnormal neuro-developmental status - non-HIE Presence of adverse 2 years neuro-developmental Outcome not attributable to perinatal hypoxic-ischemic brain injury up to 42 month age
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