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Comparing RAMS cannula and nasal mask as interface for delivery of nasal continuous positive pressure pressure in preterm neonates

Nasal continuous positive airway pressure with RAM cannula versus nasal mask in reducing the need for invasive mechanical ventilation in preterm neonates - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068826
Enrollment
210
Registered
2024-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: RAM Cannula: RAM cannula (Neotech products, INC, Valencia USA) is a FDA approved binasal prong used as interface for delivering nCPAP (nasal continuous positive airway pressure). Durat

Sponsors

Dr Nikhil Srivastav
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inborn preterm neonates less than 34 weeks of gestation with respiratory distress syndrome within 6 hours of life

Exclusion criteria

Exclusion criteria: Major congenital malformation, including chromosomal anomalies, which interfere with respiration or putting the newborn on nCPAP and severe perinatal asphyxia with 5 min Apgar score less than 3

Design outcomes

Primary

MeasureTime frame
Need for invasive mechanical ventilation within 72 hours of nCPAP applicationTimepoint: 72 hours

Secondary

MeasureTime frame
Incidence and severity of Nasal traumaTimepoint: 72 hours

Countries

India

Contacts

Public ContactDr Pradeep Kumar Debata

Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi

drpkdebata@gmail.com7291000664

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 7, 2026