Role of low dose steroids in pediatric ARDS (PARDS)

Phase 1

Recruiting

Conditions: Health Condition 1: null- Children with ARDS who are mechanically ventilation (invasive), fulfilling the PALICC criteria

Registration Number: CTRI/2018/06/014460

Lead Sponsor: Rajalakshmi Iyer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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 PIC

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess, in pediatric ARDS, treated with low dose IV methylprednisolone, <br/ ><br>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) <br/ ><br>ii.Time taken to extubation <br/ ><br>As compared to those receiving placeboTimepoint: From enrolment to either extubation, or death

Secondary Outcome Measures

Name	Time	Method
To compare the aforementioned groups for <br/ ><br>1. 28 day ventilator free days <br/ ><br>2. Mortality <br/ ><br>3. Lung injury scores <br/ ><br>4. PELOD scores (initial 7 days of enrolment) and SOFA scores <br/ ><br>5. Incidence of sepsis/ HCAI and other complications related to glucocorticoid therapy <br/ ><br>6. Number (proportion) of adverse events following steroids <br/ ><br>7. Length of PICU stay <br/ ><br>8. Length of hospital stayTimepoint: From enrolment to extubation or death