Fetal Assessment of the Myocardium and Evaluation of the Neonate
Launched by OSLO UNIVERSITY HOSPITAL · Dec 15, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The FAME-n clinical trial is studying new ways to assess the heart health of unborn babies and newborns to help prevent serious conditions like asphyxia, which is when a baby doesn't get enough oxygen at birth. The goal is to find out which babies might be at risk so that doctors can step in quickly to improve their care and outcomes. This trial is also looking at how mothers' breathing during labor affects their babies' oxygen levels and overall health.
To participate in this trial, women who are in labor and their newborns can be included after both parents give consent. The trial is using a special method to monitor the baby's heart during labor. However, some babies may not be eligible if they have severe conditions like major heart defects or if they need special cooling treatment due to lack of oxygen. Participants will be helping researchers gather important information that could lead to better care for mothers and babies in the future.
Gender
ALL
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.
About Oslo University Hospital
Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oslo, , Norway
Patients applied
Trial Officials
Åsa Waldum, PhD
Principal Investigator
Oslo University Hospital
Anne Lee Solevåg, MD, PhD
Principal Investigator
Oslo University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported