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Corticosteroids before extubation in pediatric intensive care unit: a prospective randomized double-blind multicenter study
EU CTIS ID: 2023-504829-39-00
What this study is testing
To evaluate the effectiveness of DXM-IV in reducing the incidence of DRPE/OVAS in children hospitalized in URP versus placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients intubated with an intubation tube with or without a cuff
- o Peak inspiratory pressure ≤ 22 cmH2O or cough present
- Full-term newborns, i.e., 37 weeks of amenorrhea (GA)+ 2 days until 6 years
- Affiliated to a social security system
- Collection of free and informed consent from parental authority, by both parents or by the legal guardian(s)
- Under VM for at least 36 hours
You likely can't join if
- Patient with a contraindication to DXM-IV:
- o Current digestive hemorrhage
- o Known hypersensitivity to DXM-IV or one of its excipients
- Patient participating in another interventional research involving humans or being in the exclusion period following previous research involving humans, if applicable
- Patient benefiting from State Medical Aid,
- Premature newborn (<37 weeks of pregnancy)
See the full eligibility criteria
- Patients intubated with an intubation tube with or without a cuff
- o Peak inspiratory pressure ≤ 22 cmH2O or cough present
- Full-term newborns, i.e., 37 weeks of amenorrhea (GA)+ 2 days until 6 years
- Affiliated to a social security system
- Collection of free and informed consent from parental authority, by both parents or by the legal guardian(s)
- Under VM for at least 36 hours
- And presenting the following extubation criteria:
- o Extubation planned by the medical team,
- o Inspired fraction of oxygen (FiO2) ≤ 45%
- o Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate depending on the pathology,
- o Positive expiratory pressure (Pep) ≤ 8 cmH2O
- Patient with a contraindication to DXM-IV:
- o Current digestive hemorrhage
- o Known hypersensitivity to DXM-IV or one of its excipients
- Patient participating in another interventional research involving humans or being in the exclusion period following previous research involving humans, if applicable
- Patient benefiting from State Medical Aid,
- Premature newborn (<37 weeks of pregnancy)
- Pre-existing corticosteroid therapy within 72 hours prior to randomization
- Suffering from a known upper airway pathology (VAS) before intubation or at the time of extubation
- History of VAS surgery in the month preceding inclusion
- Any situation deemed incompatible with the child's participation in the trial is left to the free estimation of the investigating doctor
- Decision to limit or stop treatments
- o Uncontrolled local or general infection,
- o Developing viruses (hepatitis, herpes, chickenpox, shingles),
- o Live vaccines,
- o Severe coagulation disorders,
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.