Skip to content

Comparison of two different interfaces for delivering non-invasive ventilation in preterm neonates

Nasopharyngeal prongs vs RAM cannula for delivering non-invasive positive pressure ventilation: An open-label randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055835
Enrollment
150
Registered
2023-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: P228- Other respiratory distress of newborn Health Condition 2: P220- Respiratory distress syndrome of newborn Health Condition 3: P221- Transient tachypnea of newborn

Interventions

Intervention1: Nasopharyngeal prongs: Neonates will receive NIPPV via Nasopharyngeal prongs as an interface and will be looked for the need of intubation within 72 hours of initiation of NIPPV. Contro

Sponsors

Dr Deepak Chawla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All inborn neonates admitted in NICU who fulfill the following criteria will be enrolled: 1. Gestation age at birth – 280/7 to 366/7 weeks 2. Receiving non-invasive positive pressure ventilation (NIPPV) for 1. A primary mode of respiratory support 2. Post- extubation respiratory support 3. Within 6 hours of initiation of NIPPV 4. Postnatal age = 28 days The neonate once randomized to the study group will remain allocated to that group for the first instance of respiratory support – for both the primary mode of respiratory support and for post-extubation support.

Exclusion criteria

Exclusion criteria: 1. Major congenital malformations 2. Pulmonary air leaks at the time of enrolment 3. Refractory shock at the time of enrolment

Design outcomes

Primary

MeasureTime frame
Need for intubation within 72 hours after initiation of NIPPVTimepoint: Need for intubation within 72 hours after initiation of NIPPV

Secondary

MeasureTime frame
Duration of invasive ventilation, NIPPV, & NCPAP (hours)Timepoint: till Hospital stay;Incidence & grade of nasal traumaTimepoint: till the use of interface for NIPPV;Need for intubationTimepoint: 72 hours to 7 days of initiation of NIPPV;Need for surfactant administrationTimepoint: till hospital stay

Countries

India

Contacts

Public ContactDr Deepak Chawla

Government Medical College, Chandigarh

drdeepak.chawla@gmail.com9646121559

Outcome results

None listed

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