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Comparison of two nasal cannulas for giving non-invasive breathing support in preterm babies

Comparison of Different Types of Cannula with Long and Narrow Tubing (CLNT) in the Administration of Non-Invasive Ventilation (NIV) in Preterm Neonates: An Exploratory Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103932
Enrollment
120
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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: CLNT R TYPE - RAM Canunula: Non Invasive ventilation (CPAP/NIPPV) delivered using RAM nasal cannula as primary respiratory support in preterm neonates with respiratory distress for 18 m

Sponsors

KASTURBA MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates with birth weight more than 1000 gm for whom Non Invasive Ventilation (NIV) is being initiated as primary non-invasive respiratory support soon after birth

Exclusion criteria

Exclusion criteria: 1)Neonates with major congenital malformations/orofacial anomalies/ suspected chromosomal anomaly 2)Extramural babies

Design outcomes

Primary

MeasureTime frame
Failure of Non Invasive VentilationTimepoint: within 72 hours after initiation of Non-invasive Ventilation (NIV)—

Secondary

MeasureTime frame
Treatment failure rates after 72 hours.Timepoint: 72 hours till discharge;Effectiveness of pressure delivery with different CLNTs as assessed by number of adjustments of cannula needed in a day Timepoint: Within the first 72 hours;Incidence and severity of nasal injuryTimepoint: During hospital stay;Ease of use and handling of the device by nursing staffTimepoint: During hospital stay;Requirement of surfactant therapyTimepoint: During hospital stay;Complications of prematurity including bronchopulmonary dysplasia, hemodynamically significant patent ductus arteriosus, necrotizing enterocolitis, culture positive sepsis, ventilator associated pneumonia, intraventricular hemorrhage, and retinopathy of prematurity requiring treatmentTimepoint: During hospital stay;Occurrence of air leak syndromesTimepoint: During hospital stay;Duration of invasive and non invasive respiratory supportTimepoint: During hospital stay;Time taken to achieve full enteral feedsTimepoint: During hospital stay;Length of hospital stayTimepoint: Up to discharge;Overall mortalityTimepoint: During hospital stay—

Countries

India

Contacts

Public ContactDr. Patlolla Shanti

Kasturba Medical College, Manipal

Patlolla.kmcmpl2024@learner.manipal.edu8790977767

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026