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Comparison of the efficacy of two bubble nasal Continuous Positive Airway Pressure delivery system in neonates with respiratory difficulty

Comparison of efficacy of new Bubble-CPAP Device (Saans) when compared to the Traditional Bubble-CPAP Device in neonates with Respiratory Distress Syndrome (RDS): A Randomized Controlled Trial (RCT)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054532
Enrollment
196
Registered
2023-06-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: P229- Respiratory distress of newborn, unspecified

Interventions

Intervention1: SAANS bubble CPAP: The neonates randomized to this arm will receive CPAP through new SAANS CPAP machine. The neonate will be continued with the same machine till it improves or discharg

Sponsors

InnAccel Technologies Private Limited
Lead Sponsor
Fernandez Foundation
Collaborator
Fernandez Hospital Educational and Research Foundation
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with respiratory distress onset before 6 hours of life and were born after 28 weeks of gestation and weighing more than 750 gms at birth and hemodynamically stable

Exclusion criteria

Exclusion criteria: Neonates with asphyxia, Hydrops or major congenital malformations.

Design outcomes

Primary

MeasureTime frame
CPAP failure definition : Need for Intubation and Ventilation or need for non invasive ventilationTimepoint: CPAP failure definition : Need for Intubation and Ventilation or need for non invasive ventilation in the first 3 days of life—

Secondary

MeasureTime frame
Air leak syndrome / pneumothoraxTimepoint: Till neonate on CPAP;Duration of respiraory supportTimepoint: Dischrge;Incidence of BPDTimepoint: 28 days of life;Intraventricular hemorrhage Grade 3 or moreTimepoint: Till 14 days of life;ROP requiring LASER/ Rx Timepoint: 44 weeks of gestaion;Surfactant requirement Timepoint: 72 hours—

Countries

India

Contacts

Public ContactTejo pratap Oleti

Fernandez Foundation

tejopratap@gmail.com9989372490

Outcome results

None listed

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