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Respiratory Effect of the LISA Method with Sedation by Propofol Versus Absence of Sedation.
Sponsor: University Hospital, Grenoble
Summary
The investigators propose to evaluate premedication with Propofol compared to a control strategy including a placebo with a possible rescue treatment with ketamine to ensure pain control before LISA Procedure . Investigators hypothesize that sedation with Propofol is safe and non-inferior to placebo for the risk of Mechanical Ventilation in the 72 hours following the procedure.
Official title: Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method with Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
233
Start Date
2019-10-07
Completion Date
2026-10
Last Updated
2024-12-12
Healthy Volunteers
No
Interventions
Propofol-Lipuro
sedation of babies \< 32wGA with propofol / placebo before a LISA Procedure
Placebos
injected to babies \< 32wGA with propofol / placebo before a LISA Procedure
Locations (13)
centre hospitalier deTroyes
Troyes, aube, France
CHU Grenoble Alpes
Grenoble, Isère, France
Chu Amiens
Amiens, France
Chu Angers
Angers, France
Chu Brest
Brest, France
Chu Chambery
Chambéry, France
Chi Creteil
Créteil, France
Chu Limoges
Limoges, France
Ap-H Marseille
Marseille, France
Chu Nantes
Nantes, France
Chu Nimes
Nîmes, France
Chi Poissy St Germain
Poissy, France
Ch Rennes
Rennes, France