Paediatric Ards Neuromuscular Blockade Study

ARDS Clinical Trial

— PAN  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02902055
• Other study ID #: PAN.1
• Status: Suspended
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 178
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS

Intervention

Drug:
• Neuromuscular Blocking Agents
Neuromuscular blockae
• Isotonic saline
Placebo

Locations

Country	Name	City	State
Netherlands	UMC Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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