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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2024-10-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ministère chargé de la santé/AOR21034 Code DGOS PHRCI-2021-08

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To evaluate the effectiveness of DXM-IV in reducing the incidence of DRPE/OVAS in children hospitalized in URP versus placebo

Secondary objectives 6

1. Evaluation of the extubation failure rate
2. Identification of risk factors for post-extubation respiratory distress in children
3. Evaluate the effect of DXM-IV on the length of stay in URP
4. Evaluate the number of days free of ventilatory assistance in URP
5. Evaluer le délai de sevrage de la ventilation non-invasive
6. Evaluation of the safety of DXM-IV in this indication with research into side effects.

Conditions and MedDRA coding

respiratory distress due to upper airway obstruction in child

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Patients intubated with an intubation tube with or without a cuff
2. Affiliated to a social security system
3. Collection of free and informed consent from parental authority, by both parents or by the legal guardian(s)
4. Under VM for at least 36 hours
5. And presenting the following extubation criteria:
6. o Extubation planned by the medical team,
7. o Inspired fraction of oxygen (FiO2) ≤ 45%
8. o Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate depending on the pathology,
9. o Positive expiratory pressure (Pep) ≤ 8 cmH2O
10. o Peak inspiratory pressure ≤ 22 cmH2O or cough present
11. Full-term newborns, i.e., 37 weeks of amenorrhea (GA)+ 2 days until 6 years

Exclusion criteria 15

1. Patient with a contraindication to DXM-IV:
2. Suffering from a known upper airway pathology (VAS) before intubation or at the time of extubation
3. History of VAS surgery in the month preceding inclusion
4. Any situation deemed incompatible with the child's participation in the trial is left to the free estimation of the investigating doctor
5. Decision to limit or stop treatments
6. o Uncontrolled local or general infection,
7. o Developing viruses (hepatitis, herpes, chickenpox, shingles),
8. o Live vaccines,
9. o Severe coagulation disorders,
10. o Current digestive hemorrhage
11. o Known hypersensitivity to DXM-IV or one of its excipients
12. Patient participating in another interventional research involving humans or being in the exclusion period following previous research involving humans, if applicable
13. Patient benefiting from State Medical Aid,
14. Premature newborn (<37 weeks of pregnancy)
15. Pre-existing corticosteroid therapy within 72 hours prior to randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 6

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Stéphane DAUGER

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Stéphane DAUGER

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications