Asphyxia Associated Metabolite Biomarker Investigation (AAMBI) (AAMBI)

• ClinicalTrials.gov Identifier: NCT03354208
• Recruitment Status: Completed
• First Posted: November 27, 2017
• Last Update Posted: January 12, 2021
• Sponsor: Life Science Inkubator
• Collaborators: Cukurova University; University Children's Hospital Tuebingen
• Information provided by (Responsible Party): Life Science Inkubator

Study Description

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.

Condition or disease	Intervention/treatment
Asphyxia Neonatorum	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 155 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 14 Days
• Official Title: Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: December 27, 2017
• Actual Study Completion Date: December 27, 2017

Groups and Cohorts

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)

Outcome Measures

Primary Outcome Measures :

1. abnormal short-term outcome (NE) [ Time Frame: 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.

Biospecimen Retention:   Samples Without DNA

blood plasma

Eligibility Criteria

• Ages Eligible for Study: 0 Hours to 2 Hours (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Infants at risk for perinatal hypoxic-ischemic brain injury

Criteria

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

Contacts and Locations

Locations

Turkey

Cukurova University

Adana, Turkey, 01330

University of Firat

Elazığ, Turkey

Özel Güngören Hastanesi

İstanbul, Turkey, 34164

Mersin University School of Medicine

Mersin, Turkey, 33343

Sponsors and Collaborators

Life Science Inkubator

Cukurova University

University Children's Hospital Tuebingen

Investigators

• Study Director: Ron Meyer; Life Science Inkubator Betriebs GmbH & Co. KG

More Information

Additional Information:

• Responsible Party: Life Science Inkubator
• ClinicalTrials.gov Identifier: NCT03354208
• Other Study ID Numbers: AAMBI I
• First Posted: November 27, 2017
• Last Update Posted: January 12, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Life Science Inkubator:

biomarkers

Additional relevant MeSH terms:

Asphyxia Neonatorum; Asphyxia; Death; Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases