Status:
ACTIVE_NOT_RECRUITING
Respiratory Effect of the LISA Method with Sedation by Propofol Versus Absence of Sedation.
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Respiratory Distress Syndrome in Premature Infant
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 P...
Detailed Description
Non-inferiority trial comparing Propofol versus placebo during the intra tracheal Less Invasive Surfactant Administration (LISA) in preterm babies \< 32 weeks of gestation for the need for mechanical ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT04016246
Start Date
October 7 2019
End Date
October 1 2026
Last Update
December 12 2024
Active Locations (13)
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1
centre hospitalier deTroyes
Troyes, aube, France, 10000
2
CHU Grenoble Alpes
Grenoble, Isère, France, 38043
3
Chu Amiens
Amiens, France, 80000
4
Chu Angers
Angers, France, 49000