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COBEX-PED Corticosteroids before extubation in pediatric intensive care unit: a prospective randomized double-blind multicenter study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504829-39-00
Acronym
APHP220674
Enrollment
348
Registered
2024-10-25
Start date
2025-10-28
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory distress due to upper airway obstruction in child

Brief summary

Cumulative incidence of DRPE/OVAS within 48 hours post-extubation

Detailed description

Cumulative incidence of reintubation due to DRPE/OVAS within 48 hours of planned extubation, Odds-Ratios associated with the occurrence of DRPE/OVAS ratio within 48 hours post-extubation, Number of days of hospitalization in URP, Calculation of the number of days free of ventilatory assistance in URP, Calculation of the number of days with non-invasive ventilation post-extubation, Incidence of side effects of DXM-IV occurring from randomization to 48 hours post-extubation.

Interventions

DRUGDEXAMETHASONE PHOSPHATE
DRUGPlacebo of dexamethasone

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of DRPE/OVAS within 48 hours post-extubation

Secondary

MeasureTime frame
Cumulative incidence of reintubation due to DRPE/OVAS within 48 hours of planned extubation, Odds-Ratios associated with the occurrence of DRPE/OVAS ratio within 48 hours post-extubation, Number of days of hospitalization in URP, Calculation of the number of days free of ventilatory assistance in URP, Calculation of the number of days with non-invasive ventilation post-extubation, Incidence of side effects of DXM-IV occurring from randomization to 48 hours post-extubation.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026