Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)

Life Science Inkubator

Status

Completed

Conditions

Asphyxia Neonatorum

Treatments

Other: blood sampling

Study type

Observational

Funder types

Other

Identifiers

NCT03354208

AAMBI I

Details and patient eligibility

About

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

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

155 patients

Sex

All

Ages

Under 2 hours old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Group 1: inclusion criteria fulfilled for hypothermia treatment Group 2: Infants with suspected perinatal brain injury due to one of the followings

Perinatal hypoxia-ischemia (defined as a perinatal acidosis indicated by a pH≤7.10 or a base excess ≤-12mmol/l in umbilical cord blood or early postnatal blood collected at <90min of age (outborn patients)
5min APGAR-score ≤ 5
Need for resuscitation after birth for >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube, or cardiac compressions Group 3: UApH >7,25, and adaptation disorder of the newborn and need of postnatal clinical surveillance

Exclusion criteria

gestational age < 36 weeks