An observational study in Newborn Asphyxia, Hemodynamic Instability and Myocardium; Ischemic, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 0 Hours to 1 Hour. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Oslo University Hospital · Observational
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.
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 unanswered. The very small population of infants with severe compromise and requiring advanced delivery room resuscitation and therapeutic hypothermia represents only the tip of the iceberg of infants that die or survive with neurological impairment. Thus, the majority of infants with a poor outcome are difficult to distinguish from those with a healthy survival. This challenge persists because currently used markers of perinatal asphyxia are inadequate and unspecific. Better methods to diagnose and monitor hypoxia-ischemia are called for.
The project will characterize in detail both normal and failed (resulting in perinatal asphyxia) transition from fetal to neonatal life. We will study the fetal/neonatal heart throughout perinatal transition, as a continuum and a single physiological entity. This cross-disciplinary approach is groundbreaking as it challenges current clinical practice, knowledge and research. Innovative use of existing technology contributes to further exploring the heart to provide prognostic information and guide supportive therapy.
The target group is fetuses and newborn infants with mild to moderate perinatal asphyxia, i.e., "uncomplicated" infants at birth that later die or develop brain injury.
Our research question is whether immediate neonatal electrocardiogram (ECG) corresponds to fetal ECG as monitored by cardiotocography (CTG) with ST-segment analysis (STAN), and whether neonatal ECG morphology differentiates between infants with mild to moderate perinatal asphyxia and healthy infants. Umbilical cord blood biomarkers, clinical outcomes and secondarily, cardiac output will be used to answer the research question.
For the Epi-FOMO study arm - maternal blood samples during labor will be drawn from an arterial line. The Epi-FOMO participants are a subset of those included in FAME-n, and we will include an equal number of delivering women with and without epidural analgesia. The hypothesis is that epidural analgesia affects maternal breathing and gas exchange, which in turn affects fetal gas exchange and the condition of the newborn infant. We believe that measurement of amniotic fluid lactate during labor may serve as "proof of concept" that maternal respiration during labor modifies the risk of perinatal asphyxia.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's planned enrollment of 220 is close to the median of 200 across 27 observational studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 Criteria:
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.
Term infants monitored with cardiotocography with ST-segment analysis (STAN) during labour: No maternal epidural labor analgesia
Other: Monitoring with Neobeat heart rate meter · Other: Maternal arterial blood gases · Other: Amniotic fluid lactate
Term infants monitored with cardiotocography with ST-segment analysis (STAN) during labour: With maternal epidural labor analgesia
Other: Monitoring with Neobeat heart rate meter · Other: Maternal arterial blood gases · Other: Amniotic fluid lactate
At 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.
Also known as: Umbilical cord blood withdrawal and Monitoring with impedance cardiography
Arterial 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 will be collected (2mL) and analyzed at pre-specified time points after rupture of the membranes.
Neonatal ECG
Blindly categorized neonatal ECG
Time frame: From birth until 10 minutes of age
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 indication
Cardiac output
Cardiac output
Time frame: From birth at least until 10 minutes of age
STAN
Blindly categorized STAN ECG raw data
Time frame: 10 minutes prior to delivery
Autonomic function
Umbilical cord blood metanephrines
Time frame: At the designated time for cord clamping as per clinical indication
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 time
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 time
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Nov 2030, 95 months after the start.
Of 16 observational studies under Asphyxia Neonatorum, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 95 months is above that.
How these figures are worked out, and which studies are left out of them.
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