Newborn AsphyxiaFAME-nNCT06186973
Fetal Assessment of the Myocardium and Evaluation of the Neonate
An observational study of Newborn Asphyxia and Hemodynamic Instability, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 hours to 1 hour
- Conditions the study is for
- Newborn Asphyxia, Hemodynamic Instability, Myocardium; Ischemic
- What is being tested?
- Monitoring with Neobeat heart rate meter, Maternal arterial blood gases and Amniotic fluid lactate
- How many people
- 220 participants
- Where
- 1 siteNorway
- Study dates
- 14 Nov 2022to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 hours to 1 hour
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0424
Anne Lee Solevåg, MD, PhD, +4741469314, lans@ous-hf.no
Åsa Waldum, PhD, +4748261713, awaldum@ous-hf.no
About this study
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.
Read the 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.
- Conditions
- Newborn Asphyxia, Hemodynamic Instability, Myocardium; Ischemic, Fetal Distress, Labor Pain
- Being tested
- Monitoring with Neobeat heart rate meter, Maternal arterial blood gases, Amniotic fluid lactate
- Medical subject headings
- Asphyxia Neonatorum, Coronary Artery Disease, Fetal Distress, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring with Neobeat heart rate meterOther
Also called Umbilical cord blood withdrawal and Monitoring with impedance cardiography
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.
Maternal arterial blood gasesOther
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 lactateOther
Amniotic fluid will be collected (2mL) and analyzed at pre-specified time points after rupture of the membranes.
| Study group | Role | What they receive |
|---|---|---|
| No maternal epidural labor analgesia | Term infants monitored with cardiotocography with ST-segment analysis (STAN) during labour: No maternal epidural labor analgesia Receives: 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 Receives: Other: Monitoring with Neobeat heart rate meter; Other: Maternal arterial blood gases; Other: Amniotic fluid lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal ECG
Blindly categorized neonatal ECG
Measured: From birth until 10 minutes of age
Cardiac enzymes
Umbilical cord blood cardiac enzymes: Creatine kinase (CK)-MB and troponin T
Measured: At the designated time for cord clamping as per clinical indication
Cardiac output
Cardiac output
Measured: From birth at least until 10 minutes of age
STAN
Blindly categorized STAN ECG raw data
Measured: 10 minutes prior to delivery
Secondary outcomes (1)
Autonomic function
Umbilical cord blood metanephrines
Measured: At the designated time for cord clamping as per clinical indication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start14 Nov 2022
- Primary completion13 Nov 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn AsphyxiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Anne Lee Solevåg, Oslo University Hospital
- Investigators
- Åsa Waldum, PhD, Principal investigator, Oslo University HospitalAnne Lee Solevåg, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186973
- Sponsor's protocol ID
- 28911
- Acronym
- FAME-n
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Assessment of the Myocardium and Evaluation of the Neonate
- ClinicalTrials.gov ID
- NCT06186973
- Acronym / sponsor ID
- FAME-n / 28911
- Conditions
- Newborn Asphyxia, Hemodynamic Instability, Myocardium; Ischemic, Fetal Distress, Labor Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 13 Nov 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No maternal epidural labor analgesia | – | Other: Monitoring with Neobeat heart rate meter, Other: Maternal arterial blood gases, Other: Amniotic fluid lactateTerm infants monitored with cardiotocography with ST-segment analysis (STAN) during labour: No maternal epidural labor analgesia |
| With maternal epidural labor analgesia | – | Other: Monitoring with Neobeat heart rate meter, Other: Maternal arterial blood gases, Other: Amniotic fluid lactateTerm infants monitored with cardiotocography with ST-segment analysis (STAN) during labour: With maternal epidural labor analgesia |
Who may qualify
- Ages
- 0 hours to 1 hour
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring with Neobeat heart rate meterAlso: Umbilical cord blood withdrawal and Monitoring with impedance cardiographyAt 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 | No maternal epidural labor analgesia, With maternal epidural labor analgesia |
| Maternal arterial blood gasesArterial 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 | No maternal epidural labor analgesia, With maternal epidural labor analgesia |
| Amniotic fluid lactateAmniotic fluid will be collected (2mL) and analyzed at pre-specified time points after rupture of the membranes. | Other | No maternal epidural labor analgesia, With maternal epidural labor analgesia |
Primary outcome
Neonatal ECG
Time frame: From birth until 10 minutes of age
Blindly categorized neonatal ECG
Cardiac enzymes
Time frame: At the designated time for cord clamping as per clinical indication
Umbilical cord blood cardiac enzymes: Creatine kinase (CK)-MB and troponin T
Cardiac output
Time frame: From birth at least until 10 minutes of age
Cardiac output
STAN
Time frame: 10 minutes prior to delivery
Blindly categorized STAN ECG raw data
1 secondary outcome
Autonomic function
Time frame: At the designated time for cord clamping as per clinical indication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Åsa Waldum, PhD principal investigator
Oslo University Hospital
Anne Lee Solevåg, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Asphyxia and Hemodynamic Instability, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Lee Solevåg, MD, PhD (+4741469314, a.l.solevag@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal ECG (time frame: From birth until 10 minutes of age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.