Prone Position in infantS/Children With Acute Respiratory Distress Syndrome (NCT06020404) | Clinical Trial Compass
UnknownNot Applicable
Prone Position in infantS/Children With Acute Respiratory Distress Syndrome
Italy15 participantsStarted 2023-09-01
Plain-language summary
In adult patients with acute respiratory distress syndrome (ARDS), the beneficial effects of prone position (PP) have been well investigated and explored; it reduces intrapulmonary shunt (Qs/Qt) and enhances lung recruitment, modifying both lung ventilation (VA) and lung perfusion (Q) distribution, finally generating an improvement in VA/Q matching and reversing oxygenation impairment;it reduces right ventricular afterload, increase cardiac index in subjects with preload reserve and reverse acute cor pulmonale in severe ARDS patients, but in infants and children there is still a lack of clear evidence. Taken together, these effects explain why PP improves oxygenation, limits the occurrence of ventilator-induced lung injury and improves survival.
Prone position is simple to perform in infants and in some neonatal and pediatric intensive care units is already commonly accomplished. However, a detailed analysis of the respective effects of high PEEP and prone position is lacking in infants/children with ARDS, while these two tools may interfere and/or act coherently. A recent multicenter, retrospective analysis of patients with pediatric acute respiratory distress syndrome (PARDS) describes how patients managed with lower PEEP relative to FIO2 than recommended by the ARDSNet model had higher mortality, suggesting that future clinical trials targeting PEEP management in PARDS are needed. We designed a physiological study to investigate the physiological effects of prone positioning on lung recruitability in infants/children with acute respiratory distress syndrome.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PaO2/FiO2 \< 200 in the supine position, with a standard PEEP of 5 cmH2O;
* PaCO2 \<45mmHg;
* Absence of history of chronic respiratory disease or heart failure or congenital heart disease (Modified Ross heart failure classification for children \< II);
* Not underweight infants/children defined as a low body mass index (BMI) for age;
* Absence of any contraindication to PP (Appendix 1);
* Written informed consent of both parents and the legal guardian.
Exclusion Criteria:
* Barotrauma;
* Less than 4 weeks of age (new-born physiology);
* Exacerbation of asthma;
* Chest trauma;
* Pulmonary oedema/haemorrhage;
* Severe Neutropenia (\<500 WBC/mm3);
* Haemodynamic instability (Systolic blood pressure \< 5th percentile or mean arterial pressure \< 5th percentile adjusted by age);
* Lactic acidosis (lactate \>5 mmol/L) and/or clinically diagnosed shock;
* Metabolic Acidosis (pH \<7.30 with normal- or hypo-carbia);
* Chronic kidney failure requiring dialysis before PICU admission;
* Upper gastrointestinal bleeding.
* Refusal to sign written informed consent of both parents and the legal guardian.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
effect of prone positioning on lung recruitability
Timeframe: at the end of the supine and prone position