Using prone positioning to improve oxygenation in infants and children with acute respiratory distress syndrome

Physiological Effects of Prone vs. sUpine Position on Lung Recruitability in infantS/Children With Acute Respiratory Distress Syndrome

This study is testing if lying infants and children with breathing problems on their stomachs can help them breathe better and get more oxygen.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Locations: 1 site (Rome)
• Trial ID: NCT06020404 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of prone positioning on infants and children suffering from acute respiratory distress syndrome (ARDS). The study will evaluate patients who meet specific oxygenation criteria and will involve a series of ventilatory maneuvers to assess respiratory mechanics and oxygenation levels. Participants will be monitored while alternating between supine and prone positions to determine the optimal settings for improving lung function and oxygenation. The trial aims to fill the knowledge gap regarding the efficacy of prone positioning in pediatric populations, which has been well established in adults but remains unclear for younger patients.

Who should consider this trial

Good fit: Ideal candidates for this study are infants and children with acute respiratory distress syndrome and a PaO2/FiO2 ratio of less than 200 mmHg.

Not a fit: Patients with chronic respiratory diseases, congenital heart conditions, or those under 4 weeks of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance oxygenation and survival rates in infants and children with ARDS.

How similar studies have performed: While prone positioning has shown success in adult ARDS patients, this study is novel as it specifically targets the pediatric population, where evidence is currently lacking.

Eligibility criteria

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.

Where this trial is running

Rome

• Giorgio Conti — Rome, Italy (Recruiting)

Conditions Prone Position; Acute Respiratory Distress Syndrome