The effect of medication that induces paralysis in children with life-threatening acute respiratory failure.

Phase 1

• Conditions: Pediatric Acute Respiratory Distress Syndrome necessitating mechanical ventilation; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-003670-40-NL
• Lead Sponsor: Beatrix Children's Hospital, University Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-06
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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
- Sedation defined by Comfort – B scale between 11 - 17
Are the trial subjects under 18? yes
Number of subjects for this age range: 178
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 1 hour before meeting PARDS criteria
- 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
- Expected duration of mechanical ventilation less than 48 hours
- Withdrawal of life–sustaining treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified