Using prone positioning during ECMO for children with severe ARDS

Efficiency and Safety of Prone Position During Extracorporeal Membrane Oxygenation in Pediatric Patients With Severe Acute Respiratory Distress Syndrome: A Multi-center Randomized Study

This study is testing if turning children with severe lung problems onto their stomachs while on ECMO can help them breathe better and recover faster.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 7 (estimated)
• Ages: 1 Month to 18 Years
• Sex: All
• Sponsor: Seventh Medical Center of PLA General Hospital (Academic / other)
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT06369584 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of prone positioning ventilation in pediatric patients with severe Acute Respiratory Distress Syndrome (PARDS) who are receiving Extracorporeal Membrane Oxygenation (ECMO) support. The study aims to address the lack of evidence-based recommendations regarding the necessity of prone positioning in this patient population. Eligible participants include children who have been on ECMO for less than 48 hours and meet specific inclusion criteria. The trial is being conducted across multiple hospitals in China to gather data on outcomes related to this intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are pediatric patients aged 1 month to 18 years with severe PARDS who have recently started ECMO support.

Not a fit: Patients who are older than 18 years, younger than 1 month, or have undergone prolonged CPR prior to ECMO initiation are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival rates and treatment outcomes for children suffering from severe PARDS.

How similar studies have performed: While previous studies have shown mixed results regarding ECMO's effectiveness in severe PARDS, this approach of using prone positioning during ECMO is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Severe PARDS and meets the criteria for ECMO support, has received ECMO support for less than 48 hours.
* Informed consent obtained from the child's direct/legal guardian

Exclusion Criteria:

1. Age \< 1 month or \> 18 years old.
2. ECMO initiated for more than 48 hours.
3. Children who have undergone cardiopulmonary resuscitation (CPR) for more than 10 minutes before ECMO initiation without restoration of spontaneous circulation, or children undergoing extracorporeal cardiopulmonary resuscitation (ECPR).
4. Presence of irreversible brain injury or intracranial hypertension.
5. Children with irreversible lung disease awaiting lung transplantation.
6. Children with abdominal trauma or postoperative acute respiratory distress syndrome (ARDS).
7. Children in whom percutaneous cannulation cannot be performed due to unstable hemodynamics within the first 48 hours after ECMO support initiation.
8. Other contraindications for performing percutaneous cannulation.
9. Liver failure.
10. Burn area \>20% body surface area (BSA).

Where this trial is running

Beijing, Beijing Municipality and 7 other locations

• Seventh medical center of Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Gansu Provincial Maternal and Child Health Care Hospital — Lanzhou, Gansu, China (Recruiting)
• The Second School of Clinical Medicine, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• Shenzhen Bao'an Maternity & Child Health Hospital — Shenzhen, Guangdong, China (Recruiting)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Recruiting)
• Henan Children's Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Xi'an Children's Hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Xiaoyang Hong, M.D.

Conditions Pediatric Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation; Extracorporeal Membrane oxygenation; pediatric acute respiratory distress syndrome; prone position ventilation