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Ventilation with chest down position in children with serious lung injury

Early prone ventilation in mild to moderate pediatric acute respiratory distress syndrome (PARDS) - A randomised clinical trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043299
Enrollment
126
Registered
2022-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: J80- Acute respiratory distress syndrome

Interventions

Intervention1: Prone positioning: Children in the intervention group will be ventilated in the prone position. Proning will be initiated within 24 hours of initiation of invasive ventilation (within s

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 1 month to 12 years admitted to PICU, 2. Requiring invasive mechanical ventilation, and 3. Fulfilling the PALICC criteria for the diagnosis of mild to moderate PARDS.

Exclusion criteria

Exclusion criteria: 1. Severe hemodynamic instability 2. Burns, trauma 3. Increased intracranial pressure

Design outcomes

Primary

MeasureTime frame
Ventilator free daysTimepoint: At 28 days

Secondary

MeasureTime frame
Duration of mechanical ventilationTimepoint: Till 28 days after randomisation or till discharge, death or transfer out from PICU, whichever is earlier;Oxygenation index at 24 and 48 hoursTimepoint: 24 and 48 hours after initiation of study;Proportion with progression to severe ARDSTimepoint: Till 28 days after randomisation or till discharge, death or transfer out from PICU, whichever is earlier;Trend in the daily Sequential Organ Failure Assessment (SOFA) scoresTimepoint: Till 28 days after randomisation or till discharge, death or transfer out from PICU, whichever is earlier;28-day mortalityTimepoint: 28 days after study initiation;Incidence of adverse events related to prone positioningTimepoint: Till 28 days after randomisation or till discharge, death or transfer out from PICU, whichever is earlier

Countries

India

Contacts

Public ContactDr Karthi N

PGIMER

ny.karthi@gmail.com9814376716

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026