Asphyxia Associated Metabolite Biomarker Investigation 2

NCT04714502 — Unknown, 144 participants, InfanDx AG

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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

Registry	NCT04714502, acronym AAMBI2
Status	Unknown
Study type	Observational
Enrollment	144 (Actual)
Sponsor	InfanDx AG (Industry); collaborators: Cukurova University, University Children's Hospital Tuebingen
Conditions	Birth Asphyxia
Dates	start 2019-07-02, primary completion 2020-10-31, completion 2021-12-31 (estimated), first posted 2021-01-19, last updated 2021-01-19
Locations	4 sites in Turkey (Türkiye)

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Infants enrolled in AAMBI1

+Outcome measures

Primary outcomes

Participants with normal neuro-developmental status [up to 42 month age]: All infants with normal neuro-developmental status
Participants with potentially abnormal neuro-developmental status [up to 42 month age]: All infants who do not fulfill outcomes 1, 3 or 4
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 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

+Eligibility

Sex: All, ages: 22 Months to 48 Months

Inclusion Criteria:

* Infants previously enrolled in the AAMBI1 study

Exclusion Criteria:

* Missing valid written informed parental consent

+Locations (4)

Facility	City	Country
Turkey Cukurova University	Adana	Turkey (Türkiye)
University of Firat	Elâzığ	Turkey (Türkiye)
Özel Güngören Hastanesi	Istanbul	Turkey (Türkiye)
Mersin University School of Medicine	Mersin	Turkey (Türkiye)

+Investigators

Ron Meyer, Study director, InfanDx AG