Rationale: Paediatric acute respiratory distress syndrome (ARDS) is a manifestation of severe, life-threatening lung injury. Care for paediatric patient is mainly supportive and based on what works in adults and personal experiences, including the use of mechanical ventilation. However, differences in lung physiology and immunology between (young) children and adults suggests that adaptation of adult practices into paediatrics may not be justified. A study in adults with severe ARDS showed that early use of neuromuscular blocking agents (NMBA) improved 90-day survival and increased time off the ventilator without increasing muscle weakness.
Objective: To test the hypothesis that early use of neuromuscular blocking agents for 48 hours in paediatric patients younger than 5 years of age with moderate – to – severe paediatric ARDS will lead to at least a 20% reduction in respiratory morbidity respiratory morbidity 12 months after discharge from the paediatric intensive care unit (PICU).
Study design: Prospective multicentre randomised double blind placebo controlled trial.
Study population: Mechanically ventilated children younger than 5 years of age are admitted to one of the eight Dutch PICUs in the university medical centres and fulfil the criteria for moderate-to-severe paediatric ARDS.
Intervention: Randomisation between continuous infusion of rocuronium bromide 1 mg/kg/hr or 0.1 ml/kg/hr isotonic saline (NaCl 0.9%) (control).
Main study parameters/endpoints: The main study parameter is the cumulative respiratory morbidity score 12 months after PICU discharge, adjusted for confounding by age, gestational age, family history of asthma and/or It is important to study the effects of neuromuscular blocking agents on patient outcome in the paediatric context. There are numerous differences in lung physiology and immunology between (young) children and adults indicating that adaptation of adult practices into paediatrics may not be justified.