Health Trials

Corticosteroids Before Extubation in Pediatric Intensive Care Unit

ConditionIntensive Care Pediatric
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-6
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Extubation planned by the medical team

Disqualifiers

Refusal of consent by at least one parent or by the legal guardian(s),

Uncontrolled local or general infection,

Active viral infections (hepatitis, herpes, chickenpox, shingles),

Live vaccines,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Placebo

    Other intervention

    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).

Treatment groups

348 Participants
are divided into 2 treatment groups
Group A: Intravenous dexamethasoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Within 48 hours post-extubation

Secondary outcomes

1

Cumulative incidence of reintubation due to RDUAO

Time frame
Within 48 hours following a planned extubation
2

Odds ratios associated with the occurrence of RDUAO

Time frame
Within 48 hours post-extubation
3

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

Time frame
Up to 28 days
4

Number of ventilator-free days in PICU

Time frame
Up to 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
Apply now