Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paediatric Ards Neuromuscular Blockade Study (PAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02902055
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Kneyber, University Medical Center Groningen

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

Condition or disease Intervention/treatment Phase
ARDS Drug: Neuromuscular Blocking Agents Drug: Isotonic saline Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Life-threatening Acute Respiratory Failure in Children: to Breathe or Not to Breathe Spontaneously, That's the Question
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024

Arm Intervention/treatment
Active Comparator: Rocuronium 1 mg/kg i.v.
Neuromuscular blocking agent
Drug: Neuromuscular Blocking Agents
Neuromuscular blockae

Active Comparator: Isotonic saline Drug: Isotonic saline
Placebo




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902055


Contacts
Layout table for location contacts
Contact: Martin Kneyber, MD PhD FCCM (+)3150-3614215 m.c.j.kneyber@umcg.nl

Locations
Layout table for location information
Netherlands
UMC Groningen Recruiting
Groningen, Netherlands
Contact: Michelle Rudolph         
Sponsors and Collaborators
University Medical Center Groningen

Layout table for additonal information
Responsible Party: Martin Kneyber, Chief, division of paediatric critical care medicine / Project leader, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02902055    
Other Study ID Numbers: PAN.1
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs