Last reviewed · How we verify
NCT06186973: FAME-n
Fetal Assessment of the Myocardium and Evaluation of the Neonate
trial testing Monitoring with Neobeat heart rate meter in Newborn Asphyxia in 220 participants. Currently enrolling.
13 November 2030
Quick facts
| Lead sponsor | Oslo University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 220 |
| Start date | 14 November 2022 |
| Primary completion | 13 November 2030 |
| Estimated completion | 31 December 2035 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Monitoring with Neobeat heart rate meter
- Maternal arterial blood gases
- Amniotic fluid lactate
Conditions studied
- Newborn Asphyxia — all drugs for Newborn Asphyxia →
- Hemodynamic Instability — all drugs for Hemodynamic Instability →
- Myocardium; Ischemic — all drugs for Myocardium; Ischemic →
- Fetal Distress — all drugs for Fetal Distress →
Sponsor
Oslo University Hospital
Who can join
Adults 0 Hours to 1 Hour, any sex, with Newborn Asphyxia or Hemodynamic Instability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06186973
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Newborn Asphyxia
Currently open trials in the same condition.
- NCT06693817 — Advanced Wireless Sensors for Neonatal Care in the Delivery Room · NA · recruiting
- NCT06394453 — Is Feeding During Therapeutic Hypothermia Safe and Can Improve Outcomes in Infants With Hypoxic-ischaemic Encephalopathy · NA · recruiting
- NCT05889507 — Cooling in Mild Encephalopathy · Phase 3 · recruiting
- NCT05395195 — Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial) · Phase 3 · recruiting
Other Oslo University Hospital trials
Trials by the same sponsor.
- NCT07463885 — Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure · NA · not yet recruiting
- NCT07427719 — Retinopathy of Prematurity - Visual Function and Retinal Structure · not yet recruiting
- NCT07403331 — Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to R · NA · recruiting
- NCT07449897 — Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study · recruiting
- NCT06173817 — The Use of Isocapnic Hyperventilation (iHV) for Treatment of Methanol Poisoned Patients · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06186973 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
- Last refreshed: 18 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06186973.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing