Pediatric ARDS.
Ira M Cheifetz
https://pubmed.ncbi.nlm.nih.gov/28546374Actively Recruiting
Phase Not Applicable
Age: 0 - 12Months
All Genders
ID05002478
Short-Term Effect of Prone Positioning in Infants with Severe Acute Respiratory Distress Syndrome
Led by Medical University of Vienna · Updated on 2024-11-20
14
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the short-term effects of prone positioning in infants with infection-associated severe acute respiratory distress syndrome (ARDS). ARDS is a serious lung condition causing inflammation, fluid buildup, and difficulty in oxygen exchange, leading to respiratory failure. The study focuses on infants hospitalized in intensive care units who require mechanical ventilation and surfactant therapy, seeking to compare the impact of prone versus supine positioning on lung function and oxygenation. Participants will be randomly assigned to one of two groups after receiving surfactant treatment: one group will be placed in the prone position for six hours before being turned to supine, while the other group remains in the supine position. During and after these positions, lung function and ventilation distribution will be measured using non-invasive tools such as electrical impedance tomography (EIT) and lung ultrasound (LUS). Throughout the study, infants will undergo assessments including oxygen saturation index changes, lung ultrasound scoring, and measurements of lung volume and tidal volume distribution at baseline and after six hours. These evaluations aim to monitor lung aeration and oxygenation improvements. The total participation includes mechanical ventilation support with monitoring to understand the benefits and effects of prone positioning in this vulnerable infant population.
CONDITIONS
Brief Title
Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial
Who Can Participate
Age: 0 - 12Months
All Genders
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
- Intracranial pressure >30 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
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 hours
Participants receive surfactant administration followed by prone or supine positioning. Oxygenation and lung function are monitored.
1 treatment period with monitoring
Follow-up
Duration - Immediately after treatment
Participants undergo evaluations using Electrical Impedance Tomography (EIT) and Lung Ultrasound (LUS) to assess lung function changes after positioning.
1 follow-up assessment visit
Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Loading map...
Research Team
T
Tobias Werther
M
Michael Hermon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Paediatric acute respiratory distress syndrome incidence and epidemiology (PARDIE): an international, observational study.
Robinder G Khemani, Lincoln Smith, Yolanda M Lopez-Fernandez...
https://pubmed.ncbi.nlm.nih.gov/30361119Mechanical ventilation strategies in children with acute lung injury: a survey on stated practice pattern*.
Miriam Santschi, Adrienne G Randolph, Peter C Rimensberger...
https://pubmed.ncbi.nlm.nih.gov/23842587The Current State of Pediatric Acute Respiratory Distress Syndrome.
Kirsten E Orloff, David A Turner, Kyle J Rehder
https://pubmed.ncbi.nlm.nih.gov/31236307Adjunctive treatments in pediatric acute respiratory distress syndrome.
Yee Hui Mok, Jan Hau Lee, Kyle J Rehder...
https://pubmed.ncbi.nlm.nih.gov/25119574Prone position in acute respiratory distress syndrome. Rationale, indications, and limits.
Luciano Gattinoni, Paolo Taccone, Eleonora Carlesso...
https://pubmed.ncbi.nlm.nih.gov/24134414Surfactant therapies for pediatric and neonatal ARDS: ESPNIC expert consensus opinion for future research steps.
Daniele De Luca, Paola Cogo, Martin C Kneyber...
https://pubmed.ncbi.nlm.nih.gov/33618742Erratum to: Surfactants in Acute Respiratory Distress Syndrome in Infants and Children: Past, Present and Future.
Angela Amigoni, Andrea Pettenazzo, Valentina Stritoni...
https://pubmed.ncbi.nlm.nih.gov/28589372Multicenter, randomized, controlled study of porcine surfactant in severe respiratory syncytial virus-induced respiratory failure.
Marco Luchetti, Federica Ferrero, Carla Gallini...
https://pubmed.ncbi.nlm.nih.gov/12780967Surfactant therapy for bronchiolitis in critically ill infants.
Kana R Jat, Deepak Chawla
https://pubmed.ncbi.nlm.nih.gov/26299681