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Role of continous positive positive pressure (CPAP) delivering devices in Meconium aspiration syndrome (aspiration of fecal contents in utero) in newborn

Randomized Control trial of Continuous positive airway pressure versus Standard care in neonates with moderate meconium aspiration syndrome in reducing the need for invasive ventilation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/03/005631
Enrollment
132
Registered
2015-03-13
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- Neonates with Meconium Aspiration Syndrome

Interventions

Intervention1: CPAP group: Infants randomized to CPAP group would be started on bubble CPAP (Fischer &Paykel) with appropriate sized Hudson prongs. The starting CPAP pressures would be 5cm of water an

Sponsors

Fernandez Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates born with MSL, developed respiratory distress with Downeâ??s score > 4 and having typical chest X-ray appearance with • Oxygen saturation • Downeâ??s score > 4 • Gestation >35 weeks and birth weight >2kgs • Less than 6 hours of life

Exclusion criteria

Exclusion criteria: Neonates with poor respiratory efforts requiring intubation and ventilation, pulmonary air leak syndromes, shock requiring inotropic support and blood pressure with MAP

Design outcomes

Primary

MeasureTime frame
Need for invasive mechanical ventilation in the first 7 days of life will be the primary outcome.Timepoint: 7 days of life—

Secondary

MeasureTime frame
DeathTimepoint: till discharge;Duration of hospitalizationTimepoint: Till discharge / death;Duration of oxygenTimepoint: till discharge / death;Duration of ventilationTimepoint: till discharge /death;PneumothoraxTimepoint: till the baby on CPAP—

Countries

India

Contacts

Public ContactDr Tejopratap Oleti

Fernadez Hospital

tejopratap@gmail.com9989372490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 25, 2026