Informations générales (source: ClinicalTrials.gov)
Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method with Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial. (PROLISA)
Interventional
Phase 3
University Hospital, Grenoble (Voir sur ClinicalTrials)
octobre 2019
octobre 2026
13 décembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Xavier DURRMEYER | 29/03/2024 01:28:32 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHI POISSY ST-GERMAIN | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ch Rennes - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Chu Brest - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble Alpes - 38043 - Grenoble - Isère - France | Contact (sur clinicalTrials) | ||||
| Chu Limoges - 87000 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Chu Nantes - 44000 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ap-H Marseille - 13000 - Marseille - France | Contact (sur clinicalTrials) | ||||
| centre hospitalier deTroyes - 10000 - Troyes - Aube - France | Contact (sur clinicalTrials) | ||||
| Chu Amiens - 80000 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Chu Angers - 49000 - Angers - France | Contact (sur clinicalTrials) | ||||
| Chu Chambery - 73000 - Chambéry - France | Contact (sur clinicalTrials) | ||||
| Chu Nimes - 30000 - Nîmes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Preterm Infants < 32 wGA (weeks of gestational age)
- Presenting a RDS (respiratory distress syndrome)
- in the first 48 hours of life
- treated by CPAP (continuous positive airway pressure) or BiPAP (Bilevel
Positive Airway Pressure)
- requiring surfactant :
- FIO2 : (fraction of inspired oxygen)
- if 28 - 31 SA : FiO2 ≥30% for a duration ≥ 10mn
- if <28 SA FIO2 ≥25% for a duration ≥10mn
- SpO2 (arterial oxygen saturation) : to obtain a SpO2 between ≥88 and ≤ 95%
- Available IntraVenous line (peripheral, umbilical or central catheter)
- Recipient of the French Social Security
- Informed consent form signed
- Preterm Infants < 32 wGA (weeks of gestational age)
- Presenting a RDS (respiratory distress syndrome)
- in the first 48 hours of life
- treated by CPAP (continuous positive airway pressure) or BiPAP (Bilevel
Positive Airway Pressure)
- requiring surfactant :
- FIO2 : (fraction of inspired oxygen)
- if 28 - 31 SA : FiO2 ≥30% for a duration ≥ 10mn
- if <28 SA FIO2 ≥25% for a duration ≥10mn
- SpO2 (arterial oxygen saturation) : to obtain a SpO2 between ≥88 and ≤ 95%
- Available IntraVenous line (peripheral, umbilical or central catheter)
- Recipient of the French Social Security
- Informed consent form signed
- Congenital and/or major malformations
- FIO2 >60%
- Silverman score >6
- Contraindication to the use of Propofol :
- Low Blood Pressure with 2 successive measurements (Mean < Gestational Age expressed
in Weeks of Gestation) persisting after one volume expansion,
- Use of inotropic medication to maintain a normal blood pressure.
- Use of sedative or analgesic drugs (except paracetamol and ibuprofen) in the
previous 24h
- Coma, convulsions, areactivity at neurological examination