Pediatric Ards Neuromuscular blockade (PAN) study: Life-threatening acute respiratory failure in children: to breathe or not to breathe spontaneously, that's the question. A multicentre, randomised, double-blind, placebo controlled study.

Phase 4

Completed

• Conditions: Paediatric acute respiratory distress syndrome; 10038716

• Registration Number: NL-OMON46725
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 178

Inclusion Criteria

- Informed consent
- Age younger than 5 years
- Need for invasive mechanical ventilation with PEEP 5 cmH2O
- Early moderate - to - severe paediatric acute respiratory distress syndrome originating from any cause:
* Acute onset of disease, and
* Oxygenation index > 12, and
* One or more (bilateral) infiltrates on chest radiograph, and
* No evidence of left ventricular failure or fluid overload, and
* Within the first 96 hours of PICU admission
- Arterial line or central venous line present

Exclusion Criteria

- No informed consent
- Known allergy or intolerance to rocuronium
- Continuous administration of neuromuscular blockade prior at the time of meeting the criteria for paediatric acute respiratory distress syndrome
- Bolus administration of neuromuscular blockade within 1hr before meeting the criteria for paediatric acute respiratory distress syndrome
- Chronic respiratory failure on home ventilation
- Intracranial hypertension
- Bone marrow transplantation
- Pre-existing pulmonary hypertension
- Congenital heart disease with left - to - right shunting
- Cyanotic congenital heart disease
- (Suspected) underlying neuromuscular or metabolic disorder
- Expected duration of mechanical ventilation less than 48 hours
- Withdrawal of life-sustaining treatment or other treatment limitations

Study & Design

• Study Type: Interventional
• Study Design: Not specified