Paediatric Ards Neuromuscular Blockade Study

NCT ID: NCT02902055

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2024-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rocuronium 1 mg/kg i.v.

Neuromuscular blocking agent

Group Type: ACTIVE_COMPARATOR

Neuromuscular Blocking Agents

Intervention Type: DRUG

Neuromuscular blockae

Isotonic saline

Group Type: ACTIVE_COMPARATOR

Isotonic saline

Intervention Type: DRUG

Placebo

Interventions

Neuromuscular Blocking Agents

Neuromuscular blockae

Intervention Type: DRUG

Isotonic saline

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Martin Kneyber

Chief, division of paediatric critical care medicine / Project leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UMC Groningen

Groningen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 35101098 (View on PubMed)

Other Identifiers

PAN.1

Identifier Type: -

Identifier Source: org_study_id