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NCT06369584: PEPAD
Prone Position During ECMO in Pediatric Patients With Severe ARDS
NA trial testing prone position in Pediatric Acute Respiratory Distress Syndrome in 7 participants. Currently enrolling.
1 May 2025
Quick facts
| Lead sponsor | Seventh Medical Center of PLA General Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 9 May 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 July 2025 |
| Sites | 8 locations across China |
Drugs / interventions tested
- prone position
Conditions studied
- Pediatric Acute Respiratory Distress Syndrome — all drugs for Pediatric Acute Respiratory Distress Syndrome →
- Extracorporeal Membrane Oxygenation — all drugs for Extracorporeal Membrane Oxygenation →
Sponsor
Seventh Medical Center of PLA General Hospital
Who can join
Adults 1 Month to 18, any sex, with Pediatric Acute Respiratory Distress Syndrome or Extracorporeal Membrane Oxygenation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO). In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly. ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F\<80mmHg or Oxygen Index (OI) \>40 for over 4 hours or OI \>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06369584
- Europe PMC full search
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Related trials
Other trials of prone position
Trials testing the same drug.
- NCT06061796 — Physiological Study of Prone Position in Acute Respiratory Failure Syndrome · NA · unknown
- NCT05712135 — Investigation of Endotracheal Cuff Pressure Changes According to Different Positions in Neurosurgery Cases · unknown
- NCT05630443 — Effects of Prone Position After Major Abdominal Surgery · NA · recruiting
- NCT05387356 — Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU · unknown
- NCT04834947 — Hemodynamic Effect of Prone Position in Non-intubated Patient With COVID 19 · unknown
Other recruiting trials for Pediatric Acute Respiratory Distress Syndrome
Currently open trials in the same condition.
- NCT06684119 — Pediatric Positive End Expiratory Pressure (PEEP) Titration Using Electrical Impedence Tomography (EIT) · NA · recruiting
Other Seventh Medical Center of PLA General Hospital trials
Trials by the same sponsor.
- NCT07458529 — Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer · Phase 2 · recruiting
- NCT05330871 — Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years. · Phase 2 · unknown
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 NCT06369584 (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 Seventh Medical Center of PLA General Hospital
- Last refreshed: 10 June 2024
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/NCT06369584.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing