NCT06186973 Fetal Assessment of the Myocardium and Evaluation of the Neonate
| NCT ID | NCT06186973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Newborn Asphyxia |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2022-11-14 |
| Primary Completion | 2030-11-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2022-11-14 with a primary completion date of 2030-11-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Åsa Waldum, PhD
PRINCIPAL INVESTIGATOR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT06186973 clinical trial?
This trial is open to participants of all sexes, aged 0 Hours or older, up to 1 Hour, studying Newborn Asphyxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06186973 currently recruiting?
Yes, NCT06186973 is actively recruiting participants. Contact the research team at a.l.solevag@medisin.uio.no for enrollment information.
Where is the NCT06186973 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT06186973 clinical trial?
NCT06186973 is sponsored by Oslo University Hospital. The principal investigator is Åsa Waldum, PhD at Oslo University Hospital. The trial plans to enroll 220 participants.