Paediatric Ards Neuromuscular Blockade Study

Study Overview
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Brief Summary
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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. It is unknown if this is also true for paediatric ARDS

Official Title
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Life-threatening Acute Respiratory Failure in Children: to Breathe or Not to Breathe Spontaneously, That's the Question

Conditions
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ARDS

Intervention / Treatment
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* Drug: Neuromuscular Blocking Agents
* Drug: Isotonic saline


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Informed consent Age younger than 5 years Need for mechanical ventilation with tidal volume 5 - 8 mL/kg ideal bodyweight and PEEP equal to or greater than 5 cmH2O Early moderate - to - severe paediatric acute respiratory distress syndrome originating from any cause, i.e. acute onset of disease, and oxygenation index greater than 12, and one or more (bilateral) infiltrates on chest radiograph, and no evidence of left ventricular failure or fluid overload, and within the first 48 hours of PICU admission Sedation defined by Comfort - B scale between 9 - 12 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 PARDS Chronic respiratory failure on home ventilation Intracranial hypertension Bone marrow transplantation Immunocompromised patients (congenital or acquired) Pre-existing pulmonary hypertension Congenital heart disease with left - to - right shunting Cyanotic congenital heart disease Expected duration of mechanical ventilation less than 48 hours Withdrawal of life - sustaining treatment

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rocuronium 1 mg/kg i.v.<br>Neuromuscular blocking agent | Drug: Neuromuscular Blocking Agents<br>* Neuromuscular blockae<br>|
| Active Comparator: Isotonic saline<br> | Drug: Isotonic saline<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cumulative respiratory morbidity score 12 months after PICU discharge, adjusted for confounding by age, gestational age, family history of asthma and/or allergy, season in which questionnaire was filled out and parental smoking |  | 12 months after PICU discharge |