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

• Status: Recruiting
• Trial end date: 2024-10-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Propofol

Criteria

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

Exclusion Criteria:

• 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