Intensive Care PediatricPhase 3COBEX-PEDNCT06722118
Corticosteroids Before Extubation in Pediatric Intensive Care Unit
A Phase 3 study testing Dexamethasone IV in people with Intensive Care Pediatric, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 days to 6 years
- Conditions the study is for
- Intensive Care Pediatric
- What is being tested?
- Dexamethasone IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 15 sitesFrance
- Study dates
- 28 Oct 2025to Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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%,
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- 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).
Who cannot join
- 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,
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- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 15 recruiting
- Recruiting
CHU Bordeaux - GH Pellegrin
Bordeaux
Anouk Navion, 0557821853 ext. +33, anouk.navion@chu-bordeaux.fr
- Recruiting
HFME Lyon-Bron
Bron
Fleur Cour Andlauer, 0472129736 ext. +33, fleur.cour-andlauer@chu-lyon.fr
- Recruiting
Hôpital Raymond Poincaré AP-HP
Garches
Aben Essid, 0147104615 ext. +33, aben.essid@aphp.fr
- Recruiting
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre
Luc Morin, 0145213205 ext. +33, luc.morin@aphp.fr
- Recruiting
CHU Lille
Lille
Sylvain Blanadier, 0320445962 ext. +33, sylvain.blanadier@chu-lille.fr
- Recruiting
La Timone AP-HM
Marseille
Fabrice Michel, 0413429353 ext. +33, fabrice.michel@ap-hm.fr
- Recruiting
CHRU Nancy
Nancy
Nathan Giroux, 0383154648 ext. +33, n.giroux@chru-nancy.fr
- Recruiting
Hôpital Necker AP-HP
Paris
Vanessa Lopez, 01 71 19 61 61 ext. +33, vanessa.lopez@aphp.fr
- Recruiting
Hôpital Necker
Paris
Mehdi Oualha, 01 44 49 42 19 ext. +33, mehdi.oualha@aphp.fr
- Recruiting
Hôpital Necker
Paris
Gilles Orliaguet, 0144494458 ext. +33, gilles.orliaguet@aphp.fr
- Recruiting
Hôpital Robert Debré AP-HP
Paris
Stéphane Dauger, 0140034098 ext. +33, stephane.dauger@aphp.fr
- Recruiting
Hôpital Trousseau AP-HP
Paris
Jérôme Rambaud, 0171738527 ext. +33, jerome.trousseau@aphp.fr
- Recruiting
Hôpital Haut-Lévêque CHU Bordeaux
Pessac
Julien Gotchac, 0557656828 ext. +33, Julien.gotchac@chu-bordeaux.fr
- Recruiting
CHU Strasbourg Hautepierre
Strasbourg
Françoise Zitvogel, 0388128323 ext. +33, francoise.zitvogel@chru-strasbourg.fr
- Recruiting
CHRU de Tours - Hôpital Clocheville
Tours
Julie Chantreuil, 0247474756 ext. +33, J.CHANTREUIL@chu-tours.fr
About this study
Official title: Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo
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
- Being tested
- Dexamethasone IV, Placebo
- Keywords
- Corticosteroids, Intensive Care Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone IVDrug
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).
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intravenous dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone IV |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO)
Measured: Within 48 hours post-extubation
Secondary outcomes (6)
Cumulative incidence of reintubation due to RDUAO
Measured: Within 48 hours following a planned extubation
Odds ratios associated with the occurrence of RDUAO
Measured: Within 48 hours post-extubation
Number of days of hospitalization in pediatric intensive care unit (PICU)
Measured: Up to 28 days
Number of ventilator-free days in PICU
Measured: Up to 28 days
Number of days with non-invasive ventilation (NIV) post-extubation
Measured: Up to 28 days
Incidence of IV-DXM side effects
Measured: Up to 48 hours post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start28 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care PediatricStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blind, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722118
- Sponsor's protocol ID
- APHP220674
- Acronym
- COBEX-PED
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo
- ClinicalTrials.gov ID
- NCT06722118
- Acronym / sponsor ID
- COBEX-PED / APHP220674
- Conditions
- Intensive Care Pediatric
- Keywords
- Corticosteroids, Intensive Care Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Intravenous dexamethasone | Experimental | Drug: Dexamethasone IV |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 2 days to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
- Fraction of inspired oxygen (FiO2) ≤ 45%,
Key exclusion criteria (17 listed)
- Refusal of consent by at least one parent or by the legal guardian(s),
- Patient with a contraindication to IV-DXM:
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone IVIV-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). | Drug | Intravenous dexamethasone |
| PlaceboPlacebo: 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). | Other | Placebo |
Primary outcome
Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO)
Time frame: Within 48 hours post-extubation
6 secondary outcomes
Cumulative incidence of reintubation due to RDUAO
Time frame: Within 48 hours following a planned extubation
Odds ratios associated with the occurrence of RDUAO
Time frame: Within 48 hours post-extubation
Number of days of hospitalization in pediatric intensive care unit (PICU)
Time frame: Up to 28 days
Number of ventilator-free days in PICU
Time frame: Up to 28 days
Number of days with non-invasive ventilation (NIV) post-extubation
Time frame: Up to 28 days
Incidence of IV-DXM side effects
Time frame: Up to 48 hours post-extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone IV in people with Intensive Care Pediatric, run by Assistance Publique - Hôpitaux de Paris at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Dauger, MD PhD (140032187 ext. +33, stephane.dauger@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of respiratory distress due to upper airway obstruction (RDUAO) (time frame: Within 48 hours post-extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.