Paediatric Ards Neuromuscular Blockade Study (PAN)

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

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

Study Overview

• Status: Terminated
• Conditions: ARDS
• Intervention / Treatment: Drug: Isotonic saline; Drug: Neuromuscular Blocking Agents

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • UMC Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Publications and helpful links

General Publications

• Rudolph MW, Slager S, Burgerhof JGM, van Woensel JBM, Alffenaar JC, Wosten-van Asperen RM, de Hoog M, IJland MM, Kneyber MCJ; SKIC research consortium. Paediatric Acute Respiratory Distress Syndrome Neuromuscular Blockade study (PAN-study): a phase IV randomised controlled trial of early neuromuscular blockade in moderate-to-severe paediatric acute respiratory distress syndrome. Trials. 2022 Jan 31;23(1):96. doi: 10.1186/s13063-021-05927-w.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimated): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents
• Other Study ID Numbers: PAN.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No