NCT05237232 Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children
| NCT ID | NCT05237232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Extra Corporeal Membrane Oxygenation |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-03-31 |
| Primary Completion | 2026-08 |
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 30 participants in total. It began in 2022-03-31 with a primary completion date of 2026-08.
⚠ 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
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis. This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).
Eligibility Criteria
Inclusion Criteria: For everyone : 1. Information and non-opposition of holders of parental authority 2. Newborn, infant and child \<20kg 3. Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital 4. Performing a Magnetic Resonance Angiography (MRA) as part of the treatment For patients treated with ECMO: study population 5. Hemodynamic or respiratory failure 6. Requiring the use of extracorporeal circulation with jugulo-carotid cannulation 7. Weaned alive off Extra corporeal membrane oxygenation (ECMO) For patients with hypoxic-ischemic encephalopathy: control population 8. hypoxic-ischemic encephalopathy diagnosed at birth Exclusion Criteria: 1. Contraindication to MRA 2. Opposition of holders of parental authority
Contact & Investigator
Sabine Irtan, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05237232 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Extra Corporeal Membrane Oxygenation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05237232 currently recruiting?
Yes, NCT05237232 is actively recruiting participants. Contact the research team at sabine.irtan@aphp.fr for enrollment information.
Where is the NCT05237232 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05237232 clinical trial?
NCT05237232 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Sabine Irtan, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 30 participants.