Clinical trial NCT06186973: Fetal Assessment of the Myocardium and Evaluation of the Neonate
Official title: Fetal Assessment of the Myocardium and Evaluation of the Neonate
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Newborn Asphyxia
Hemodynamic Instability
Myocardium; Ischemic
Fetal Distress
Labor Pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2024-01-02
Enrollment: 220
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Primary outcomes:
measure: Neonatal ECG
timeFrame: From birth until 10 minutes of age
measure: Cardiac enzymes
timeFrame: At the designated time for cord clamping as per clinical indication
measure: Cardiac output
timeFrame: From birth at least until 10 minutes of age
measure: STAN
timeFrame: 10 minutes prior to delivery
Secondary outcomes:
measure: Autonomic function
timeFrame: At the designated time for cord clamping as per clinical indication
Other outcomes:
measure: Maternal arterial blood gases
timeFrame: Four times during 1st stage of labor, during pushing and after delivery, maximum duration 24 hours of total labor time
measure: Amniotic fluid lactate
timeFrame: Four times during 1st stage of labor, and during pushing, maximum duration 24 hours of total labor time
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Åsa Waldum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Anne Lee Solevåg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: