Prone Position in infantS/Children With Acute Respiratory Distress Syndrome

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Aug 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of placing infants and children with Acute Respiratory Distress Syndrome (ARDS) in a "prone position," which means lying them on their stomachs. Previous research shows that this position can help improve breathing and oxygen levels in adults, but we need more information about how it works for younger patients. The goal is to understand if this method can help these children breathe better and recover from ARDS.

To participate in this study, children must have a specific level of oxygen in their blood while lying on their backs and meet other health criteria, such as not having chronic respiratory or heart conditions. Parents or guardians will need to give their written consent for their child to participate. If eligible, participants can expect to be monitored closely while researchers observe how the prone position affects their lung function. This trial aims to gather important data that could improve treatment strategies for children facing this serious condition.

Gender

ALL

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.