Corticosteroids Before Extubation in Pediatric Intensive Care Unit

NCT ID: NCT06722118

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2028-07-31

Brief Summary

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.

Conditions

Intensive Care Pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous dexamethasone

Group Type: EXPERIMENTAL

Dexamethasone IV

Intervention Type: DRUG

IV-DXM 4mg/ml, injectable solution. Dosage of 0.25 mg/kg (maximum 5 mg per dose), prepared in a syringe of 5 to 10 ml and administered intravenously to the patient over 10 minutes every 6 hours. The treatment duration ranges from 6 hours (minimum of two doses: H0, H6) to 18 hours (maximum of four doses: H0, H6, H12, H18).

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo: 0.9% NaCl solution, prepared in a syringe of 5 to 10 ml and administered intravenously to the patient over 10 minutes every 6 hours. The treatment duration ranges from 6 hours (minimum of two doses: H0, H6) to 18 hours (maximum of four doses: H0, H6, H12, H18).

Interventions

Dexamethasone IV

IV-DXM 4mg/ml, injectable solution. Dosage of 0.25 mg/kg (maximum 5 mg per dose), prepared in a syringe of 5 to 10 ml and administered intravenously to the patient over 10 minutes every 6 hours. The treatment duration ranges from 6 hours (minimum of two doses: H0, H6) to 18 hours (maximum of four doses: H0, H6, H12, H18).

Intervention Type: DRUG

Placebo

Placebo: 0.9% NaCl solution, prepared in a syringe of 5 to 10 ml and administered intravenously to the patient over 10 minutes every 6 hours. The treatment duration ranges from 6 hours (minimum of two doses: H0, H6) to 18 hours (maximum of four doses: H0, H6, H12, H18).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Stéphane Dauger, MD PhD

Role: CONTACT

stephane.dauger@aphp.fr

140032187 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

142499742 ext. +33

Other Identifiers

APHP220674

Identifier Type: -

Identifier Source: org_study_id