Asphyxia Associated Metabolite Biomarker Investigation 2

NCT04714502 | Unknown

• 1 other identifier: AAMBI2
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 4

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.

Conditions

Birth Asphyxia

Keywords

biomarkers; asphyxia; Hypoxic ischemic encephalopathy

Outcome Measures

Primary Outcomes (4)

• Participants with normal neuro-developmental status

  All infants with normal neuro-developmental status

  up to 42 month age

• Participants with potentially abnormal neuro-developmental status

  All infants who do not fulfill outcomes 1, 3 or 4

  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

  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

  up to 42 month age

Study Arms (1)

Infants enrolled in AAMBI1

Eligibility Criteria

• Age: 22 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• Infants previously enrolled in the AAMBI1 study

You may not qualify if:

• Missing valid written informed parental consent

Sponsors & Collaborators

• InfanDx AG: lead
• Cukurova University: collaborator
• University Children's Hospital Tuebingen: collaborator

Study Sites (4)

Turkey Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

University of Firat

Elâzığ, 23110, Turkey (Türkiye)

Location

Özel Güngören Hastanesi

Istanbul, 34164, Turkey (Türkiye)

Location

Mersin University School of Medicine

Mersin, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asphyxia Neonatorum; Asphyxia; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Ron Meyer

  InfanDx AG

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: July 2, 2019
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2021
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)