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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

Tracking Information
First Submitted Date September 22, 2017
First Posted Date November 27, 2017
Last Update Posted Date March 16, 2018
Actual Study Start Date October 2016
Actual Primary Completion Date December 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Official Title Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 14 Days
Biospecimen Retention:   Samples Without DNA
Description:
blood plasma
Sampling Method Probability Sample
Study Population Infants at risk for perinatal hypoxic-ischemic brain injury
Condition Asphyxia Neonatorum
Intervention Other: blood sampling
small volume blood sampling, according to local laws, is not categorized as intervention (observational study)
Study Groups/Cohorts
  • Group 1
    patients with hypoxic-ischemic encephalopathy (HIE) receiving hypothermia therapy
    Intervention: Other: blood sampling
  • Group 2
    patients with suspected HIE, non-confirmed
    Intervention: Other: blood sampling
  • Group 3
    healthy, retrospectively classified as such
    Intervention: Other: blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 15, 2018)
128
Original Estimated Enrollment
 (submitted: November 21, 2017)
110
Actual Study Completion Date December 27, 2017
Actual Primary Completion Date December 27, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Hours   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03354208
Other Study ID Numbers AAMBI I
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Life Science Inkubator
Study Sponsor Life Science Inkubator
Collaborators
  • Cukurova University
  • University Children’s Hospital Tuebingen
Investigators
Study Director: Ron Meyer Life Science Inkubator Betriebs GmbH & Co. KG
PRS Account Life Science Inkubator
Verification Date March 2018