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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
STAN is used in combination with CTG in fetuses \>36 weeks of gestation. Thus, the study population will only include infants born with a gestational age \>36 weeks.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Monitoring with Neobeat heart rate meter
Other interventionAt the designated time for cord clamping as per clinical indication, a 10 cm segment of the umbilical cord will be double-clamped and 5 ml of preferably arterial blood will be obtained. In infants brought to the resuscitation table, six ECG electrodes will be placed on the skin and cardiac output will be measured with a hemodynamic monitor (PhysioFlow®) for at least 10 min, or until the end of resuscitation/stabilization.
Maternal arterial blood gases
Other interventionArterial blood gases will be drawn from a radial artery line and analyzed at the end of a contraction at pre-specified time points during labor.
Amniotic fluid lactate
Other interventionAmniotic fluid will be collected (2mL) and analyzed at pre-specified time points after rupture of the membranes.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: No maternal epidural labor analgesia3 interventions
Group B: With maternal epidural labor analgesia3 interventions
Trial outcomes
Primary outcomes
1
Neonatal ECG
Blindly categorized neonatal ECG
Time frame
From birth until 10 minutes of age2
Cardiac enzymes
Umbilical cord blood cardiac enzymes: Creatine kinase (CK)-MB and troponin T
Time frame
At the designated time for cord clamping as per clinical indication3
Cardiac output
Cardiac output
Time frame
From birth at least until 10 minutes of age4
STAN
Blindly categorized STAN ECG raw data
Time frame
10 minutes prior to deliverySecondary outcomes
1
Autonomic function
Umbilical cord blood metanephrines
Time frame
At the designated time for cord clamping as per clinical indicationOther outcomes
1
Maternal arterial blood gases
Oxygen partial pressure (pO2) and carbondioxide partial pressure (pCO2)
Time frame
Four times during 1st stage of labor, during pushing and after delivery, maximum duration 24 hours of total labor time2
Amniotic fluid lactate
Analyzed in 2mL amniotic fluid
Time frame
Four times during 1st stage of labor, and during pushing, maximum duration 24 hours of total labor timeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
South-Eastern Norway Regional Health Authority
Collaborator
Source ClinicalTrials.gov