Modeling blood flow in children's brains after ECMO treatment
Cerebral Hemodynamic Impact in Children Depending on the Technique of Carotid Artery Decanulation Technique After Extracorporeal Membrane Oxygenation: Modeling of Intra-cerebral Vascular Flows
This study looks at how two different methods for removing ECMO affect blood flow in the brains of young children who weigh less than 20 kg.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05237232 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of extracorporeal membrane oxygenation (ECMO) on cerebral blood flow in children weighing less than 20 kg. It focuses on comparing hemodynamics based on two techniques used for carotid decanulation: reconstruction and ligation. Using Magnetic Resonance Angiography (MRA) and computational modeling, the study aims to provide insights into how these techniques impact arterial circulation and flow dynamics within the circle of Willis. The research is conducted at the pediatric and neonatal intensive care unit of Trousseau Hospital in Paris.
Who should consider this trial
Good fit: Ideal candidates include newborns, infants, and children under 20 kg who have undergone ECMO and are hospitalized in a pediatric intensive care unit.
Not a fit: Patients who are contraindicated for Magnetic Resonance Angiography or whose guardians oppose participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cerebral blood flow dynamics in children post-ECMO, potentially improving surgical techniques and patient outcomes.
How similar studies have performed: While studies on ECMO exist, this specific modeling approach in pediatric patients is relatively novel and has limited prior research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Trousseau — Paris, France (Recruiting)
Study contacts
- Principal investigator: Sabine Irtan, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Sabine Irtan, MD, PhD
- Email: sabine.irtan@aphp.fr
- Phone: 1 71 73 87 98
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.