Corticosteroids Before Extubation in Pediatric Intensive Care Unit (COBEX-PED)

Assistance Publique - Hôpitaux de Paris

Status and phase

Not yet enrolling

Phase 3

Conditions

Intensive Care Pediatric

Treatments

Other: Placebo

Drug: Dexamethasone IV

Study type

Interventional

Funder types

Other

Identifiers

NCT06722118

APHP220674

Details and patient eligibility

About

Fifty to 60% of children admitted to a pediatric intensive care unit (PICU) are placed under invasive mechanical ventilation (MV) at least once during their stay. After extubation, about 30% of these patients will experience respiratory distress due to upper airway obstruction (RDUAO), and about one-third of these cases will require re-intubation. Treating this RDUAO extends the length of stay in the PICU.

Pre-extubation corticosteroid therapy has been validated in adults as a preventive treatment for the occurrence of RDUAO. However, the lack of robust data in pediatrics has not allowed for a consensus on the benefit of its use in children on MV in the PICU.

The investigators propose to conduct a randomized, multicenter, double-blind, placebo-controlled study evaluating the effect of intravenous dexamethasone (IV-DXM) before extubation on the incidence of RDUAO in children.

Enrollment

348 estimated patients

Sex

All

Ages

2 days to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients intubated with an endotracheal tube with or without a cuff,
Aged from 2 days post-term to 6 years,
On mechanical ventilation for at least 36 hours,

And meeting the following extubation criteria:

Extubation planned by the medical team
Fraction of inspired oxygen (FiO2) ≤ 45%,
Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate according to the pathology,
Positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,
Peak inspiratory pressure ≤ 22 cmH2O or presence of cough.
Affiliated with a social security system,
Collection of informed consent from the parental authority, by both parents or the legal guardian(s).

Exclusion criteria

Refusal of consent by at least one parent or by the legal guardian(s),
Patient with a contraindication to IV-DXM:
- Uncontrolled local or general infection,
- Active viral infections (hepatitis, herpes, chickenpox, shingles),
- Live vaccines,
- Severe coagulation disorders,
- Ongoing gastrointestinal bleeding,
- Known hypersensitivity to IV-DXM or one of its excipients.
Patient participating in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable,
Patient receiving State Medical Aid,
Patient on long-term NIV,
Known upper airway pathology (UAP) before intubation or at the time of extubation,
History of UAP surgery within the month preceding inclusion,
Any situation deemed incompatible with the child's participation in the trial at the discretion of the investigating physician,
Decision to limit or stop therapeutic interventions.
Premature patients aged less than 40 weeks of gestation
Newborns aged less than 2 days after post-term birth