Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)

Completed

• Conditions: Asphyxia Neonatorum
• Interventions: Other: blood sampling

• Registration Number: NCT03354208
• Lead Sponsor: Life Science Inkubator

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Primary Completion: 2017-12-27
• Study Completion: 2017-12-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-09
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

• age at time of screening >2,5h
• congenital malformation
• missing or invalid informed parental consent
• unsuccessful resuscitation
• infant considered not-viable
• decision for palliative care only

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	blood sampling	patients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy
Group 2	blood sampling	patients with suspected HIE, non-confirmed
Group 3	blood sampling	healthy, retrospectively classified as such

Primary Outcome Measures

Name	Time	Method
abnormal short-term outcome (NE)	14 days for clinical diagnosis	All patients are classified as abnormal short-term outcome (neonatal encephalopathy, NE) or normal short term outcome (no encephalopathy) by using clinical data, particularly Thompson score. For Group 1 and group 2 patients outcome classification will be additionally confirmed by using cranial ultrasound or MRI (including severe ischemia based on DWI or thalamic or cerebellar bleeding or arterial infarction or IVH\>2° according to Papile, thalamic ischemia or severe cerebral edema) or seizure activity or burst suppression on aEEG or persistingly abnormal aEEG background pattern after complete rewarming.; Bloodplasma samples will be analysed by a metabolomics approach using the p180-kit (Biocrates, Innsbruck, Austria). Metabolite concentrations or combinations thereof will be compared to the outcome described above in order to identify the most suitable metabolites to be used for early detection of NE in newborn infants.

Trial Locations

Locations (4)

Cukurova University; 🇹🇷 Adana, Turkey

Özel Güngören Hastanesi; 🇹🇷 İstanbul, Turkey

Mersin University School of Medicine; 🇹🇷 Mersin, Turkey

University of Firat; 🇹🇷 Elazığ, Turkey