Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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.
Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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
144
Turkey Cukurova University
Adana, Turkey (Türkiye)
University of Firat
Elâzığ, Turkey (Türkiye)
Özel Güngören Hastanesi
Istanbul, Turkey (Türkiye)
Mersin University School of Medicine
Mersin, Turkey (Türkiye)
Participants with normal neuro-developmental status
All infants with normal neuro-developmental status
Time frame: up to 42 month age
Participants with potentially abnormal neuro-developmental status
All infants who do not fulfill outcomes 1, 3 or 4
Time frame: up to 42 month age
Participants with abnormal neuro-developmental status - HIE
Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury
Time frame: up to 42 month age
Participants with abnormal neuro-developmental status - non-HIE
Presence of adverse 2 years neuro-developmental Outcome not attributable to perinatal hypoxic-ischemic brain injury
Time frame: up to 42 month age
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