Fetal Assessment of the Myocardium and Evaluation of the Neonate

Summary

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

• Newborn Asphyxia
• Hemodynamic Instability
• Myocardium; Ischemic
• Fetal Distress
• Labor Pain

Interventions

OTHER

Monitoring with Neobeat heart rate meter

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.

OTHER

Maternal arterial blood gases

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.

OTHER

Amniotic fluid lactate

Amniotic fluid will be collected (2mL) and analyzed at pre-specified time points after rupture of the membranes.

Sponsors & Collaborators

• South-Eastern Norway Regional Health Authority

  collaborator OTHER

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Åsa Waldum, PhD · Oslo University Hospital

• Anne Lee Solevåg, MD, PhD · Oslo University Hospital

Eligibility

Min Age

0 Hours

Max Age

1 Hour

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-14

Primary Completion

2030-11-13

Completion

2035-12-31

Countries

• Norway

Study Locations