Validation of Biomarkers of Adverse Neurologic Outcome in Newborns Who Required Resuscitation or Are Suspected to be at Risk for Perinatal Brain Injury and Long-term Adverse Neurological Outcome A Prospective Multicenter Observational Study for Development of a Diagnostic Test
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 553
- Locations
- 11
- Primary Endpoint
- Validation of diagnostic algorithm
Study Overview
Brief Summary
Validation 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 and a preliminary human study.
Detailed Description
The aim of the study is to validate 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, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 0 Minutes to 90 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Need for resuscitation after birth: For >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only CPAP), or cardiac compressions
- •5 min APGAR-score ≤
- •Perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a pH≤7.1 in arterial umbilical cord blood or early postnatal blood collected at <30min of age
- •Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at <30min of age.
Exclusion Criteria
- •Age >1.5h
- •gestational age < 36 weeks
- •birth weight <2000g
- •congenital malformation
- •missing valid written informed parental consent
- •unsuccessful resuscitation
- •infant considered not-viable
- •decision for palliative care only
Outcomes
Primary Outcomes
Validation of diagnostic algorithm
Time Frame: 10 days
The best combinations of biomarkers from the preliminary study will be used and sensitivity and specificity as well as positive and negative likelihood ratios and their 95%-confidence limits will be calculated.
Secondary Outcomes
No secondary outcomes reported