A clinical trial to compare lower vs higher dose of dexamethasone to prevent post extubation airway obstruction in children

24-hour pre-treatment with high dose versus low dose dexamethasone in prevention of post -extubation airway obstruction in children A Randomized, open-label,controlled trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009273

Enrollment

300

Registered

2017-08-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- PEDIATRIC INTENSIVE CARE PATIENTS UNDERGOING EXTUBATION FROM VENTILATION Health Condition 2: J152- Pneumonia due to staphylococcus

Interventions

Intervention1: DEXAMETHASONE: Study group (24-hour pre-treatment with 0.25mg/Kg/dose): In this group (henceforth will be called as Group 1), patients will receive 6 doses of intravenous dexamethasone

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >3 months to 2. Intubated for >=48 hrs. 3. Undergoing their first elective extubation in the PICU.

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. Upper airway obstruction due to infection, trauma, burns, surgery as indication for intubation. 2. Corticosteroid therapy within previous 7 days. 3. Chronic treatment with NSAIDs or corticosteroids. 4. Patients likely to have poor airway reflexes as those with best motor and eye response of Glassgow Coma Score 5. A history of previous tracheal intubation or tracheostomy. 6. Congenital upper airway obstruction e.g., laryngotracheomalacia etc. 7. Chronic lung disease e.g., cystic fibrosis, bronchopulmonary dysplasia. 8. A medical condition that contraindicate the use of corticosteroids. 9. Presence of gastrointestinal bleeding, hypertension ( >95th centile) and hyperglycemia at the time of screening. 10. Patient got self-extubated or extubation was cancelled for any reason prior to completion of initial 5 doses of the intervention drug. 11. The clinical status deteriorated prior to completion of initial 5 doses of the intervention drug

Design outcomes

Primary

Measure	Time frame
Need for adrenaline nebulization any time during first 24 hours after extubationTimepoint: 24 hours after first extubation	—

Secondary

Measure	Time frame
1. Maximal WCS recorded during the time between 20min -24hours. 2. Need for re-intubation during 24 hours of extubation. 3. PICU stay after the first extubation under consideration. 4. Incidence of adverse events related to dexamethasone use.Timepoint: Upto 48 hours	—

Countries

India

Contacts

Public ContactArun Baranwal

PGIMER ,Chandigarh

baranwal1970@gmail.com07766908325

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026