Paediatric Ards Neuromuscular Blockade Study

NCT02902055 | Terminated Phase 4 DMC

• 1 other identifier: PAN.1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

ARDS

Outcome Measures

Primary Outcomes (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

  12 months after PICU discharge

Study Arms (2)

Rocuronium 1 mg/kg i.v.

ACTIVE COMPARATOR

Neuromuscular blocking agent

Drug: Neuromuscular Blocking Agents

Isotonic saline

ACTIVE COMPARATOR

Drug: Isotonic saline

Interventions

Neuromuscular Blocking Agents DRUG

Neuromuscular blockae

Rocuronium 1 mg/kg i.v.

Isotonic saline DRUG

Placebo

Isotonic saline

Eligibility Criteria

• Age: 0 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMC Groningen

Groningen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 35101098 DERIVED

MeSH Terms

Interventions

Neuromuscular Blocking Agents; Sodium Chloride

Intervention Hierarchy (Ancestors)

Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, division of paediatric critical care medicine / Project leader

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 15, 2016
• Study Start: December 1, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 7, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)