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comparing RAM cannula and nasal mask for non invasive breathing support in very preterm newborns

RAM Cannula vs Nasal mask for delivering non invasive positive pressure ventilation in very preterm neonates an open label randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099086
Enrollment
100
Registered
2025-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: 5- Extracorporeal or Systemic Assistance and Performance

Interventions

Intervention1: RAM Cannula: RAM Cannula will be used and efficacy will be studied on very preterm neonates who will fulfill the criteria of receiving non invasive positive pressure ventilation as a mo

Sponsors

Pt BD Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn neonates fulfilling the criteria for receiving non-invasive positive pressure ventilation (NIPPV) as a mode of respiratory support within 2 hours of birth.

Exclusion criteria

Exclusion criteria: Major congenital malformations, Refractory shock at the time of enrolment, Pulmonary air leaks at the time of enrolment, Consent not given by parents

Design outcomes

Primary

MeasureTime frame
It will be recorded on the basis of need for intubation within hoursTimepoint: Participants in study will be assessed on basis of need for intubation within 72 hours after initiation of NIPPV and the criteria for intubation will be any of these on maximal settings of NIPPV that is severe respiratory distress or low SpO2 or acidotic pH or high pCO2 in blood gas or significant apneas or shock needing more than one inotrope

Secondary

MeasureTime frame
It will be recorded on basis of need of intubation within days and other late neonatal morbiditiesTimepoint: Participants will be assessed on basis of outcomes that is need of intubation between 72 hours and 7 days after initiation of NIPPV, need for surfactant administration as per standard protocol, duration of invasive ventilation, NIPPV, and NCPAP in hours, incidence of neonatal morbidities like air leaks, BPD, IVH , NEC, incidence of feed intolerance, incidence of ROP needing treatment, Length of hospital stay.

Countries

India

Contacts

Public ContactDr Somya Godara

Pt BD Sharma university of health sciences Rohtak

somyagodara103@gmail.com9991843765

Outcome results

None listed

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