DEXAMETHASONE PHOSPHATE for Respiratory distress due to upper airway obstruction

Inclusion criteria

• {"criterion_text":"- Patients intubated with an intubation tube with or without a cuff\n- o Peak inspiratory pressure ≤ 22 cmH2O or cough present\n- Full-term newborns, i.e., 37 weeks of amenorrhea (GA)+ 2 days until 6 years\n- Affiliated to a social security system\n- Collection of free and informed consent from parental authority, by both parents or by the legal guardian(s)\n- Under VM for at least 36 hours\n- And presenting the following extubation criteria:\n- o Extubation planned by the medical team,\n- o Inspired fraction of oxygen (FiO2) ≤ 45%\n- o Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate depending on the pathology,\n- o Positive expiratory pressure (Pep) ≤ 8 cmH2O"}

Exclusion criteria

• {"criterion_text":"- Patient with a contraindication to DXM-IV:\n- o Current digestive hemorrhage\n- o Known hypersensitivity to DXM-IV or one of its excipients\n- Patient participating in another interventional research involving humans or being in the exclusion period following previous research involving humans, if applicable\n- Patient benefiting from State Medical Aid,\n- Premature newborn (<37 weeks of pregnancy)\n- Pre-existing corticosteroid therapy within 72 hours prior to randomization\n- Suffering from a known upper airway pathology (VAS) before intubation or at the time of extubation\n- History of VAS surgery in the month preceding inclusion\n- Any situation deemed incompatible with the child's participation in the trial is left to the free estimation of the investigating doctor\n- Decision to limit or stop treatments\n- o Uncontrolled local or general infection,\n- o Developing viruses (hepatitis, herpes, chickenpox, shingles),\n- o Live vaccines,\n- o Severe coagulation disorders,"}

Primary endpoints

• {"endpoint_text":"- Cumulative incidence of DRPE/OVAS within 48 hours post-extubation","definition_or_measurement_approach":"Assessment of cumulative incidence within 48 hours after extubation"}

Secondary endpoints

• {"endpoint_text":"- Cumulative incidence of reintubation due to DRPE/OVAS within 48 hours of planned extubation","definition_or_measurement_approach":"Assessment of cumulative incidence of reintubation within 48 hours of planned extubation"}
• {"endpoint_text":"- Odds-Ratios associated with the occurrence of DRPE/OVAS ratio within 48 hours post-extubation","definition_or_measurement_approach":"Calculation of odds-ratios for occurrence of DRPE/OVAS within 48 hours post-extubation"}
• {"endpoint_text":"- Number of days of hospitalization in URP","definition_or_measurement_approach":"Count of days hospitalized in the pediatric intensive care unit (URP)"}
• {"endpoint_text":"- Calculation of the number of days free of ventilatory assistance in URP","definition_or_measurement_approach":"Calculation of ventilator-free days during URP stay"}
• {"endpoint_text":"- Calculation of the number of days with non-invasive ventilation post-extubation","definition_or_measurement_approach":"Calculation of days with non-invasive ventilation after extubation"}
• {"endpoint_text":"- Incidence of side effects of DXM-IV occurring from randomization to 48 hours post-extubation.","definition_or_measurement_approach":"Recording incidence of adverse events from randomization up to 48 hours post-extubation"}

France

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

487

Number Of Sites

15

Number Of Participants

348

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France