Corticosteroids Before Extubation in Pediatric Intensive Care Unit

NCT06722118 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: APHP220674
• Study Type: interventional
• Target: 348
• Locations: 0 countries
• Sites: N/A

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

Keywords

Corticosteroids; Intensive Care Pediatrics

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO)

  Within 48 hours post-extubation

Secondary Outcomes (6)

• Cumulative incidence of reintubation due to RDUAO

  Within 48 hours following a planned extubation

• Odds ratios associated with the occurrence of RDUAO

  Within 48 hours post-extubation

• Number of days of hospitalization in pediatric intensive care unit (PICU)

  Up to 28 days

• Number of ventilator-free days in PICU

  Up to 28 days

• Number of days with non-invasive ventilation (NIV) post-extubation

  Up to 28 days

Study Arms (2)

Intravenous dexamethasone

EXPERIMENTAL

Drug: Dexamethasone IV

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Dexamethasone IV 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).

Intravenous dexamethasone

Placebo 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).

Placebo

Eligibility Criteria

• Age: 2 Days - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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 receiving State Medical Aid,
• Patient on long-term NIV,
• Known upper airway pathology (UAP) before intubation or at the time of extubation,
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Central Study Contacts

Stéphane Dauger, MD PhD

CONTACT

140032187; stephane.dauger@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 27, 2025

Record last verified: 2025-04