Trials / Unknown
UnknownNCT04714502
Asphyxia Associated Metabolite Biomarker Investigation 2
Verification of Biomarkers to Examine Neonatal Asphyxia-induced Hypoxic-ischemic Encephalopathy Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 144 (actual)
- Sponsor
- InfanDx AG · Industry
- Sex
- All
- Age
- 22 Months – 48 Months
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2019-07-02
- Primary completion
- 2020-10-31
- Completion
- 2021-12-31
- First posted
- 2021-01-19
- Last updated
- 2021-01-19
Locations
4 sites across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04714502. Inclusion in this directory is not an endorsement.