Asphyxia Associated Metabolite Biomarker Investigation 2

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04714502

Acronym

AAMBI2

Enrollment

144

Registered

2021-01-19

Start date

2019-07-02

Completion date

2021-12-31

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Asphyxia

Keywords

biomarkers, asphyxia, Hypoxic ischemic encephalopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Months to 48 Months

Healthy volunteers

Inclusion criteria

* Infants previously enrolled in the AAMBI1 study

Exclusion criteria

* Missing valid written informed parental consent

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Outcome results