Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186973
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2023-12-01
Brief Title:
Fetal Assessment of the Myocardium and Evaluation of the Neonate
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Fetal Assessment of the Myocardium and Evaluation of the Neonate
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAME-n
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
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 fetalneonatal 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 ie 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
The project will characterize in detail both normal and failed resulting in perinatal asphyxia transition from fetal to neonatal life We will study the fetalneonatal 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None