PROPOFOL for Neonatal respiratory distress syndrome

Inclusion criteria

• {"criterion_text":"-Preterm Infants < 32 wGA\n-Presenting a RDS  in the first 48 hours of life  treated by CPAP or BiPAP  requiring surfactant :  FIO2 : - if 28 - 31 SA : FiO2 ≥30% for a duration ≥ 10mn - if <28 SA FIO2 ≥25% for a duration ≥10mn  SpO2 : To obtain a SpO2 between ≥88 and ≤ 95%\n-Available Intra-Venous line (peripheral, umbilical or central catheter)\n-Covered by French Social Security\n-Informed consent form signed"}

Exclusion criteria

• {"criterion_text":"-Congenital and/or major malformations\n-FIO2> 60% at the time of the inclusion\n-Silverman score > 6\n-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 normal blood pressure.\n-Use of sedative or analgesic drugs (except paracetamol and ibuprofen) in the previous 24h\n-Coma, convulsions, areactivity at neurological examination"}

Primary endpoints

• {"endpoint_text":"-Rate of MV from the start of the LISA procedure up to 72 hours of life in each group.","definition_or_measurement_approach":"Measure: Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 72 hours of life in each group."}

Secondary endpoints

• {"endpoint_text":"-Rate of MV from the start of the LISA procedure up to 72 hours of life in each class of GA (<28, 28-31wGA)","definition_or_measurement_approach":"Measure: Rate of mechanical ventilation (MV) from the start of the LISA procedure up to 72 hours of life stratified by gestational age classes (<28, 28-31 wGA)."}
• {"endpoint_text":"-Faceless Acute Neonatal Scale (FANS) assessed during the LISA: this scale evaluates behavioral items (limb movements, vocal expression) and physiological items (heart rate variation, bradycardia or desaturation), on a scale from 0 (no pain) to 10 (maximal pain).","definition_or_measurement_approach":"Measure: FANS score during LISA (0-10 scale) evaluating behavioral and physiological items as specified."}
• {"endpoint_text":"-Rate of ketamine administration for rescue: This administration will be indicated after two (< 28 wGA) or 3 (28 – 31 wGA) administrations of the drug, if adequate comfort is not achieved (FANS≥6 or baby not comfortable)","definition_or_measurement_approach":"Measure: Proportion of infants receiving ketamine rescue; rescue indicated after two administrations (<28 wGA) or three administrations (28–31 wGA) if FANS ≥6 or inadequate comfort."}
• {"endpoint_text":"-Quality conditions","definition_or_measurement_approach":"Measure: Procedure quality metrics (per procedure events, tolerance) and clinician satisfaction during LISA as specified in protocol."}
• {"endpoint_text":"-To assess BPD at 36wGA","definition_or_measurement_approach":"Measure: Bronchopulmonary dysplasia (BPD) at 36 weeks gestational age according to Jobe 2001 definition with severity distinction (severe, moderate, mild). Final assessment at post-conceptional age 36 weeks."}
• {"endpoint_text":"-In-hospital neonatal morbidity and mortality","definition_or_measurement_approach":"Measure: Incidence of predefined in-hospital neonatal morbidity and mortality events."}
• {"endpoint_text":"-At two years : ASQ questionnaire, Gross Motor Function Classification Scale in cases of motor impairment, Visual and hearing function","definition_or_measurement_approach":"Measure: At two years corrected age among survivors: ASQ questionnaire results, GMFCS if motor impairment, visual and hearing function assessments."}

France

Latest Decision Or Authorization Date

22-04-2026

Number Of Sites

15

Number Of Participants

542

Primary sponsor

Full Name

Centre Hospitalier Universitaire Grenoble Alpes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France