Asphyxia Associated Metabolite Biomarker Investigation (AAMBI) (AAMBI)

Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test

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.

Study Overview

• Status: Completed
• Conditions: Asphyxia Neonatorum
• Intervention / Treatment: Other: blood sampling

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 Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01330
    • Çukurova University
  • Elazığ, Turkey
    • University of Firat
  • Mersin, Turkey, 33343
    • Mersin University School of Medicine
  • İstanbul, Turkey, 34164
    • Özel Güngören Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants at risk for perinatal hypoxic-ischemic brain injury

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; patients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy	Other: blood sampling; small volume blood sampling, according to local laws, is not categorized as intervention (observational study)
Group 2; patients with suspected HIE, non-confirmed	Other: blood sampling; small volume blood sampling, according to local laws, is not categorized as intervention (observational study)
Group 3; healthy, retrospectively classified as such	Other: blood sampling; small volume blood sampling, according to local laws, is not categorized as intervention (observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abnormal short-term outcome (NE)	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.	14 days for clinical diagnosis

Collaborators and Investigators

• Sponsor: Life Science Inkubator
• Collaborators: Cukurova University; University Children's Hospital Tuebingen
• Investigators: Study Director: Ron Meyer, Life Science Inkubator Betriebs GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 27, 2017
• Study Completion (Actual): December 27, 2017

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 9, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: biomarkers
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Death; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: AAMBI I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No