Status:
COMPLETED
Asphyxia Associated Metabolite Biomarker Investigation (AAMBI)
Lead Sponsor:
Life Science Inkubator
Collaborating Sponsors:
Cukurova University
University Children's Hospital Tuebingen
Conditions:
Asphyxia Neonatorum
Eligibility:
All Genders
Up to 2 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 27 2017
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT03354208
Start Date
October 1 2016
End Date
December 27 2017
Last Update
January 12 2021
Active Locations (4)
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1
Cukurova University
Adana, Turkey (Türkiye), 01330
2
University of Firat
Elâzığ, Turkey (Türkiye)
3
Özel Güngören Hastanesi
Istanbul, Turkey (Türkiye), 34164
4
Mersin University School of Medicine
Mersin, Turkey (Türkiye), 33343