Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02902055
Other study ID # PAN.1
Secondary ID
Status Suspended
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04435613 - Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients N/A
Enrolling by invitation NCT05020210 - Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
Completed NCT04468971 - REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia Phase 1
Completed NCT04505592 - Tenecteplase in Patients With COVID-19 Phase 2
Completed NCT04493242 - Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS Phase 2
Withdrawn NCT04909879 - Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome Phase 2
Completed NCT02265198 - Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome N/A
Completed NCT01949272 - Optimization of PEEP for Alveolar Recruitment in ARDS N/A
Not yet recruiting NCT01668368 - Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance N/A
Completed NCT01881061 - Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit N/A
Completed NCT00808691 - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit N/A
Completed NCT05035589 - The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
Recruiting NCT04764032 - Right Ventricular Dysfunction in Ventilated Patients With COVID-19
Completed NCT04556513 - Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status
Recruiting NCT06036056 - NMR Based Metabolomics Kinetics in ARDS Patients
Recruiting NCT04503876 - Effects of End-expiratory Positive Pressure Optimization in Intubated Patients With Healthy Lung or Acute Respiratory Distress Syndrome N/A
Recruiting NCT04643691 - Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS Phase 2
Completed NCT04395911 - Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections N/A
Not yet recruiting NCT05341687 - Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.
Recruiting NCT05056090 - Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome. N/A