Fetal Assessment of the Myocardium and Evaluation of the Neonate

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-1
SponsorOslo University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Monitoring with Neobeat heart rate meter
  • Maternal arterial blood gases
  • Amniotic fluid lactate

Treatment groups

220 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oslo University Hospital

Lead sponsor

South-Eastern Norway Regional Health Authority

Collaborator