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

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

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the cumulative respiratory morbidity score 12<br /><br>months after PICU discharge, adjusted for confounding by age, gestational age,<br /><br>family history of asthma and/or allergy, season in which questionnaire was<br /><br>filled out and parental smoking. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Effects of NMBAs on pulmonary and systemic inflammation<br /><br>2. Effects of NMBAs on oxygenation and ventilation<br /><br>3. Effects of NMBAs respiratory system mechanics<br /><br>4. Incidence of adverse drug reactions related to rocuronium<br /><br>a. Occurrence of hypotension or tachycardia with the need for intervention by<br /><br>means of medication or fluid challenge<br /><br>b. Number of re-intubations<br /><br>5. Concomitant use of sedatives and/or analgesics<br /><br>6. Prevalence of critical illness polyneuropathy and myopathy<br /><br>7. Prevalence of ventilator-associated pneumonia<br /><br>8. Prevalence of organ dysfunction<br /><br>9. Prevalence of withdrawal syndrome and delirium<br /><br>10. The number of ventilator-free days at day 28<br /><br>11. The length of PICU and hospital stay </p><br>