Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT06020404
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT06020404
Study Brief:
Protocol Section:
NCT06020404