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ACTIVE NOT RECRUITING
NCT04016246
PHASE3

Respiratory Effect of the LISA Method with Sedation by Propofol Versus Absence of Sedation.

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

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

DRUG

Propofol-Lipuro

sedation of babies \< 32wGA with propofol / placebo before a LISA Procedure

DRUG

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