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Asphyxia Associated Metabolite Biomarker Investigation (AAMBI) (AAMBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354208
Recruitment Status : Completed
First Posted : November 27, 2017
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
Cukurova University
University Children's Hospital Tuebingen
Information provided by (Responsible Party):
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.

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 128 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

Resource links provided by the National Library of Medicine


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)




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


Information from the National Library of Medicine

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Ages Eligible for Study:   up 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354208


Locations
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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
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Study Director: Ron Meyer Life Science Inkubator Betriebs GmbH & Co. KG
Additional Information:

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Responsible Party: Life Science Inkubator
ClinicalTrials.gov Identifier: NCT03354208    
Other Study ID Numbers: AAMBI I
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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