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Comparison of Two Binasal Short Prongs in Providing Nasal CPAP to preterm babies

Efficacy of Different Types of Binasal Short prongs Interface in Providing Nasal Continuous Positive Airway Pressure for Primary respiratory support in Preterm Neonates with Respiratory distress

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024097
Enrollment
260
Registered
2020-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: J960- Acute respiratory failure Health Condition 2: J988- Other specified respiratory disorders

Interventions

Intervention1: RAM cannula: After randomization, RAM�® nasal cannula (Neotech products, INC, Valencia USA) will be used in intervention arm for 72 hours Control Intervention1: Binasal prongs (Fisher

Sponsors

Dr Pradeep Kumar Debata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All inborn preterm neonates between 28-34 weeks of gestation and 2. weigh >1000 grams and 3. who require respiratory support within 6 hours of life due to respiratory distress syndrome

Exclusion criteria

Exclusion criteria: 1. Major congenital malformations including chromosomal anomalies, which interfere with respiration or putting the newborn on nCPAP 2. Those needing intubation after birth 3. Perinatal asphyxia (APGAR score of <5 at 5min) or encephalopathy due to any reason

Design outcomes

Primary

MeasureTime frame
nCPAP failure within 72 hours of lifeTimepoint: February 2020 TO January 2021—

Secondary

MeasureTime frame
To compare the incidence of nasal trauma with two different types of bi-nasal short prongs when used a primary mode of support for nCPAP delivery in preterm neonates between 28-34 weeks of gestation and weighing more than and equal to 1000gm with respiratory distress.Timepoint: February 2020 TO January 2021—

Countries

India

Contacts

Public ContactSk Samim

Vardhman Mahavir Medical College And Safdarjung Hospital

drpkdebata@gmail.com9868515298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 13, 2026