Actively Recruiting
Fetal Assessment of the Myocardium and Evaluation of the Neonate
Led by Oslo University Hospital · Updated on 2025-03-18
220
Participants Needed
1
Research Sites
685 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
S
South-Eastern Norway Regional Health Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 asphyxia-related illness and death. Neonatal hemodynamics may be improved by early detection of instability of the heart and circulation. Innovative use of technology enables characterization of normal and abnormal cardiovascular transition in a significantly larger number of fetuses and newborn infants than what was previously possible. The methods used may have broad generalizability and applicability in perinatal, neonatal and pediatric medicine. In September 2023, the project was expanded with an obstetric arm called Epidural analgesia: Fetal Oxygenation and Maternal Oxygenation (Epi-FOMO). In Epi-FOMO, the relationship between maternal breathing and arterial blood gases during labour, and umbilical cord blood gases and neonatal outcomes (as specified in FAME-n) will be investigated.
CONDITIONS
Official Title
Fetal Assessment of the Myocardium and Evaluation of the Neonate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women admitted for labor and newborn infants included after written consent from both parents if applicable
- Use of CTG with STAN for fetal monitoring at clinician's discretion
You will not qualify if you...
- Perinatal asphyxia requiring therapeutic hypothermia
- Major malformations or stillbirth
- Known chromosomal anomalies
- Congenital heart defects other than patent ductus arteriosus
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
Research Team
A
Anne Lee Solevåg, MD, PhD
CONTACT
K
Kathrine Samuelsen Hansen, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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