NCT06186973Recruiting
Fetal Assessment of the Myocardium and Evaluation of the Neonate
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 220 (estimated)
- First submitted
- 1 Dec 2023
- Start date
- 14 Nov 2022
- Primary completion date
- 13 Nov 2030
- Lead sponsor
- Oslo University Hospital
- NCT number
- NCT06186973
What you commit to
- Study type: Observational
- Planned participants: 220
- From 14 Nov 2022 to the primary completion date, 13 Nov 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 0 hours to 1 hour · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.