Asphyxia Associated Metabolite Biomarker Investigation 2

• Conditions: Birth Asphyxia

• Registration Number: NCT04714502
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-07-02
• Primary Completion: 2020-10-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Infants previously enrolled in the AAMBI1 study

Exclusion Criteria

• Missing valid written informed parental consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (4)

University of Firat; 🇹🇷 Elazığ, Turkey

Turkey Cukurova University; 🇹🇷 Adana, Turkey

Özel Güngören Hastanesi; 🇹🇷 Istanbul, Turkey

Mersin University School of Medicine; 🇹🇷 Mersin, Turkey