Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation. (NCT04016246) | Clinical Trial Compass
CompletedPhase 3
Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.
France233 participantsStarted 2019-10-07
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied giving surfactant to premature babies using the LISA method — with or without propofol sedation — and tracked whether babies still needed mechanical ventilation afterward; can you explain what LISA is and how it compares to the way surfactant is typically given here?
2Since this was a Phase 3 trial that has now completed, has enough data been published for you to know whether using propofol during the LISA procedure made a meaningful difference in babies' need for a breathing machine?
3Propofol is a sedative that can affect a newborn's breathing on its own — is there any concern that giving it to a premature baby during this kind of procedure could add extra respiratory risk, and what did this trial find about that?
4If my baby might be a candidate for the LISA method, would you consider using it with or without sedation, and how does what this trial found influence your practice?
5Are there standard-of-care options for surfactant delivery that you'd recommend considering before thinking about enrollment in any related ongoing studies, and how does this completed trial's evidence shape that recommendation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
need for mechanical ventilation after the procedure