Health Condition 1: null- Children with ARDS who are mechanically ventilation (invasive), fulfilling the PALICC criteria
Conditions
Interventions
Intervention1: Methyl Prednisolone: Powdered form of methyl prednisolone will be diluted to form a 1 mg in 1 mL solution, and given as infusion as:
2 mg/kg bolus dose, followed by-
1 mg/kg/day x 7 day
Sponsors
Rajalakshmi Iyer
Ashish Kumar Kakkar
Muralidharan Jayashree
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 1 month- 12 years admitted to our hospital and satisfying the criteria for the diagnosis of PARDS based on the recent pediatric specific definition proposed by Pediatric Acute Lung Injury Consensus Conference Group investigators, within the first 72 hours of admission to the PICU
Exclusion criteria
Exclusion criteria: 1. Do not get a ventilator (manual IPPR will be excluded) 2. Children on glucocorticoids > 2 weeks 3. Children who are known cases of immunosuppression 4. Known case of adrenal insufficiency 5. Known case of vasculitis 6. Children with haematological or solid organ malignancy 7. Children suspected to have diffuse alveolar haemorrhage 8. Children suspected to have invasive fungal infection 9. Known case of chronic liver disease 10. Children with history of gastrointestinal bleed within the past 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess, in pediatric ARDS, treated with low dose IV methylprednisolone, i. Time taken to reduce oxygenation index by 50% from the baseline (the worst recorded OI in the first 24 hours or at the end of 24 hours of mechanical ventilation) ii. Time taken to extubation As compared to those receiving placeboTimepoint: From enrolment to either extubation, or death | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the aforementioned groups for 1. 28 day ventilator free days 2. Mortality 3. Lung injury scores 4. PELOD scores (initial 7 days of enrolment) and SOFA scores 5. Incidence of sepsis/ HCAI and other complications related to glucocorticoid therapy 6. Number (proportion) of adverse events following steroids 7. Length of PICU stay 8. Length of hospital stayTimepoint: From enrolment to extubation or death | — |
Countries
India
Contacts
Public ContactRajalakshmi Iyer
PGIMER, Chandigarh
Outcome results
None listed