Comparison of "IN-REC-SUR-E" and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial).
Humans
Respiratory Distress Syndrome, Newborn
/ therapy
Infant, Newborn
Pulmonary Surfactants
/ administration & dosage
Infant, Premature
Treatment Outcome
Gestational Age
Continuous Positive Airway Pressure
Bronchopulmonary Dysplasia
/ therapy
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Time Factors
Airway Extubation
/ adverse effects
Intubation, Intratracheal
Female
HFOV
INRECSURE
LISA
Lung recruitment
Preterm infants
Surfactant
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
02 Jul 2024
02 Jul 2024
Historique:
received:
01
03
2024
accepted:
10
06
2024
medline:
3
7
2024
pubmed:
3
7
2024
entrez:
3
7
2024
Statut:
epublish
Résumé
Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. In this study, 382 infants born at 24 This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24 ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.
Sections du résumé
BACKGROUND
BACKGROUND
Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration.
METHODS
METHODS
In this study, 382 infants born at 24
DISCUSSION
CONCLUSIONS
This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.
Identifiants
pubmed: 38956676
doi: 10.1186/s13063-024-08240-4
pii: 10.1186/s13063-024-08240-4
doi:
Substances chimiques
Pulmonary Surfactants
0
Banques de données
ClinicalTrials.gov
['NCT05711966']
Types de publication
Journal Article
Clinical Trial Protocol
Comparative Study
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
433Informations de copyright
© 2024. The Author(s).
Références
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