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Clinical Trials/NCT02902055
NCT02902055
Terminated
Phase 4

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

University Medical Center Groningen1 site in 1 country3 target enrollmentDecember 1, 2019

Overview

Phase
Phase 4
Intervention
Neuromuscular Blocking Agents
Conditions
ARDS
Sponsor
University Medical Center Groningen
Enrollment
3
Locations
1
Primary Endpoint
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
Status
Terminated
Last Updated
last year

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
May 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martin Kneyber

Chief, division of paediatric critical care medicine / Project leader

University Medical Center Groningen

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Rocuronium 1 mg/kg i.v.

Neuromuscular blocking agent

Intervention: Neuromuscular Blocking Agents

Isotonic saline

Intervention: Isotonic saline

Outcomes

Primary Outcomes

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

Time Frame: 12 months after PICU discharge

Study Sites (1)

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