NCT05002478 Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial
| NCT ID | NCT05002478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2022-07-30 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14 participants in total. It began in 2022-07-30 with a primary completion date of 2026-07-31.
⚠ 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
The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.
Eligibility Criteria
Inclusion Criteria: * Patients hospitalized at Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) of the Medical University Vienna. * Patients aged \>36 weeks (corrected gestational age) and \<24 months. * Patient intubated and mechanically ventilated for at least 6 hours, with an expected requirement of invasive ventilatory support for at least 12 hours. * Clinical picture strongly suggestive for acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation and/or findings of new infiltrates consistent with acute pulmonary parenchymal disease on chest X-ray). * Severe pediatric acute respiratory distress syndrome (ARDS), defined by OSI ≥12.3 (wean FIO2 to maintain SpO2 ≤ 97% to calculate oxygen saturation index). * Written informed consent obtained from parents. Exclusion Criteria: * Clinical context * Need for O2 supplementation to maintain SpO2\>94% in the 4 weeks preceding hospitalization in the PICU/NICU * Cyanotic congenital heart disease Cardiogenic pulmonary edema * Severe pulmonary hypertension * Untreated pneumothorax * Severe neurological abnormalities * Other severe congenital anomalies such as congenital diaphragmatic hernia * Ongoing cardiopulmonary resuscitation or limitation of life support * Contradictions for prone positioning (adapted from Guerin, C., et al., Prone positioning in severe acute respiratory distress syndrome. N Engl J Med, 2013. 368(23): p. 2159-68): * Intracranial pressure \>30 millimeters of mercury (mmHg) in supine position or cerebral perfusion pressure \<60 mmHg * Massive hemoptysis requiring an immediate surgical or interventional radiology procedure * Tracheal surgery or sternotomy during the previous 15 days * Serious facial trauma or facial surgery during the previous 15 days * Deep venous thrombosis treated for less than 2 days * Cardiac pacemaker inserted in the last 2 days * Unstable spine, femur, or pelvic fractures * Use of extracorporeal membrane oxygenation (ECMO) before inclusion * Lung transplantation * Burns on more than 20% of the body surface * Other non-inclusion criteria * Indication not to attempt resuscitation * Patient already recruited for other clinical studies * Patients who already received surfactant in the last 4 weeks * Thoracic skin lesions or wounds on the thorax, where the EIT-electrode-belt would be placed
Contact & Investigator
Tobias Werther
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT05002478 clinical trial?
This trial is open to participants of all sexes, up to 12 Months, studying Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05002478 currently recruiting?
Yes, NCT05002478 is actively recruiting participants. Contact the research team at tobias.werther@meduniwien.ac.at for enrollment information.
Where is the NCT05002478 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT05002478 clinical trial?
NCT05002478 is sponsored by Medical University of Vienna. The principal investigator is Tobias Werther at Medical University of Vienna. The trial plans to enroll 14 participants.