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Comparative study to assess the effect of using steroids in early phase of acute lung injury with lowered oxygenation in children versus children with similar lung aliment who did not receive steroids in same early phase.

A randomised control study of early methylprednisolone therapy in pediatric ARDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015727
Enrollment
30
Registered
2018-09-14
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: J96-J99- Other diseases of the respiratory system

Interventions

Intervention1: All patients will be randomised into two groups ( A and B group). Methylprednisolone will be given for patients in group A.: For group A pateints 2 mg/kg/day IV methylprednisolone will

Sponsors

Rainbow childrens hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All children between 1 month to 18 years of age, intubated for acute hypoxemic lung injury qualifying the criteria of pediatric ARDS (mild , moderate or severe) as per the PALICC definition (2016) shall be included in the study.

Exclusion criteria

Exclusion criteria: 1.Children on CPAP/NIV/HFNC. 2.Children already receiving glucocorticoids. 3.Children who have contra-indication for use of steroids (e.g. immunosuppressed, severe burns( >30% Burns), or gastrointestinal bleed within the past 1 month. 4.Parents refusing for steroids.

Design outcomes

Primary

MeasureTime frame
Assessment of oxygenation status trends during the first 5 days( Pao2/fio2, OI, OSI, SF).Timepoint: First 5 days

Secondary

MeasureTime frame
1.Analysis of clinical outcome parameters like duration of mechanical ventilation, ventilator free days, mortality and morbidity. 2.Ventilator parameters (FiO2, Tidal volume, Compliance, plateau pressure ) 3.Need of sedation (cumulative dose of sedatives, paralytics). Timepoint: Duration of hospital stay

Countries

India

Contacts

Public ContactDr Farhan AR Shaikh

Rainbow Childrens Hospital

farhanshaikh74@gmail.com9866007602

Outcome results

None listed

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