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.
Acute respiratory distress syndrome
Children
Critical illness polyneuropathy and myopathy
Mechanical ventilation
Neuromuscular blockade
Respiratory morbidity
Respiratory morbidity score
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
31 Jan 2022
31 Jan 2022
Historique:
received:
06
09
2021
accepted:
08
12
2021
entrez:
1
2
2022
pubmed:
2
2
2022
medline:
3
2
2022
Statut:
epublish
Résumé
Paediatric acute respiratory distress syndrome (PARDS) is a manifestation of severe, life-threatening lung injury necessitating mechanical ventilation with mortality rates ranging up to 40-50%. Neuromuscular blockade agents (NMBAs) may be considered to prevent patient self-inflicted lung injury in PARDS patients, but two trials in adults with severe ARDS yielded conflicting results. To date, randomised controlled trials (RCT) examining the effectiveness and efficacy of NMBAs for PARDS are lacking. We hypothesise that using NMBAs for 48 h in paediatric patients younger than 5 years of age with early moderate-to-severe PARDS will lead to at least a 20% reduction in cumulative respiratory morbidity score 12 months after discharge from the paediatric intensive care unit (PICU). This is a phase IV, multicentre, randomised, double-blind, placebo-controlled trial performed in level-3 PICUs in the Netherlands. Eligible for inclusion are children younger than 5 years of age requiring invasive mechanical ventilation with positive end-expiratory pressure (PEEP) ≥ 5 cm H ClinicalTrials.gov NCT02902055 . Registered on September 15, 2016.
Sections du résumé
BACKGROUND
BACKGROUND
Paediatric acute respiratory distress syndrome (PARDS) is a manifestation of severe, life-threatening lung injury necessitating mechanical ventilation with mortality rates ranging up to 40-50%. Neuromuscular blockade agents (NMBAs) may be considered to prevent patient self-inflicted lung injury in PARDS patients, but two trials in adults with severe ARDS yielded conflicting results. To date, randomised controlled trials (RCT) examining the effectiveness and efficacy of NMBAs for PARDS are lacking. We hypothesise that using NMBAs for 48 h in paediatric patients younger than 5 years of age with early moderate-to-severe PARDS will lead to at least a 20% reduction in cumulative respiratory morbidity score 12 months after discharge from the paediatric intensive care unit (PICU).
METHODS
METHODS
This is a phase IV, multicentre, randomised, double-blind, placebo-controlled trial performed in level-3 PICUs in the Netherlands. Eligible for inclusion are children younger than 5 years of age requiring invasive mechanical ventilation with positive end-expiratory pressure (PEEP) ≥ 5 cm H
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT02902055 . Registered on September 15, 2016.
Identifiants
pubmed: 35101098
doi: 10.1186/s13063-021-05927-w
pii: 10.1186/s13063-021-05927-w
pmc: PMC8802263
doi:
Substances chimiques
Neuromuscular Blocking Agents
0
Banques de données
ClinicalTrials.gov
['NCT02902055']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
96Subventions
Organisme : ZonMw
ID : 848041002
Informations de copyright
© 2022. The Author(s).
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