Status:
RECRUITING
Fetal Assessment of the Myocardium and Evaluation of the Neonate
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
South-Eastern Norway Regional Health Authority
Conditions:
Newborn Asphyxia
Hemodynamic Instability
Eligibility:
All Genders
Up to 1 years
Brief Summary
FAME-n aims to improve perinatal care by introducing new approaches to fetal and neonatal heart assessment. Better identification of high-risk deliveries requiring intervention will reduce perinatal a...
Detailed Description
Among the millions of infants with various degrees of perinatal asphyxia each year, the question how to identify those that without supportive measures will die or develop brain injury remains unanswe...
Eligibility Criteria
Inclusion
- Women admitted for labor and newborn infants will be included after written consent from both parents (if applicable). The final inclusion criterion is that CTG with STAN is used for fetal surveillance at clinician's discretion.
Exclusion
- Perinatal asphyxia fulfilling the criteria for therapeutic hypothermia, major malformations and stillbirth, known chromosomal anomalies or congenital heart defects other than a patent ductus arteriosus.
Key Trial Info
Start Date :
November 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06186973
Start Date
November 14 2022
End Date
December 31 2035
Last Update
March 18 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0424