Asphyxia Associated Metabolite Biomarker Investigation 2 (AAMBI2)

InfanDx

Status: Unknown

Conditions: Birth Asphyxia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04714502

AAMBI2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 22 to 48 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants previously enrolled in the AAMBI1 study

Exclusion criteria

• Missing valid written informed parental consent

Trial design

144 participants in 1 patient group

Infants enrolled in AAMBI1