Paediatric Ards Neuromuscular Blockade Study (PAN)

University Medical Center Groningen (UMCG)

Status and phase: Terminated; Phase 4

Conditions: ARDS

Treatments: Drug: Neuromuscular Blocking Agents; Drug: Isotonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02902055

PAN.1

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

3 participants in 2 patient groups

Rocuronium 1 mg/kg i.v.

Active Comparator group

Description:

Neuromuscular blocking agent

Treatment:

Drug: Neuromuscular Blocking Agents

Isotonic saline

Active Comparator group

Treatment:

Drug: Isotonic saline