Fetal Assessment of the Myocardium and Evaluation of the Neonate

NCT06186973 | Recruiting

• 1 other identifier: 28911
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Neonatal ECG

  Blindly categorized neonatal ECG

  From birth until 10 minutes of age

• Cardiac enzymes

  Umbilical cord blood cardiac enzymes: Creatine kinase (CK)-MB and troponin T

  At the designated time for cord clamping as per clinical indication

• Cardiac output

  Cardiac output

  From birth at least until 10 minutes of age

• STAN

  Blindly categorized STAN ECG raw data

  10 minutes prior to delivery

Secondary Outcomes (1)

• Autonomic function

  At the designated time for cord clamping as per clinical indication

Other Outcomes (2)

• Maternal arterial blood gases

  Four times during 1st stage of labor, during pushing and after delivery, maximum duration 24 hours of total labor time

• Amniotic fluid lactate

  Four times during 1st stage of labor, and during pushing, maximum duration 24 hours of total labor time

Study Arms (2)

No maternal epidural labor analgesia

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

With maternal epidural labor analgesia

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

Interventions

Monitoring with Neobeat heart rate meter OTHER

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

No maternal epidural labor analgesia; With maternal epidural labor analgesia

Maternal arterial blood gases OTHER

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.

No maternal epidural labor analgesia; With maternal epidural labor analgesia

Amniotic fluid lactate OTHER

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

No maternal epidural labor analgesia; With maternal epidural labor analgesia

Eligibility Criteria

• Age: 0 Hours - 1 Hour
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Umbilical cord blood - preferably arterial Maternal arterial blood gases from the radial artery

MeSH Terms

Conditions

Asphyxia Neonatorum; Coronary Artery Disease; Fetal Distress; Labor Pain

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Åsa Waldum, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Anne Lee Solevåg, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Lee Solevåg, MD, PhD

CONTACT

+4741469314; a.l.solevag@medisin.uio.no

Kathrine Samuelsen Hansen, MSc

CONTACT

+4791711476; kathrine_samuelsen@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant physician

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 2, 2024
• Study Start: November 14, 2022
• Primary Completion (Estimated): November 13, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

NO (1)