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High Velocity Nasal Insufflation versus Continuous Positive Airway Pressure as an Initial Respiratory Support in Preterm Neonates with Respiratory Distress Syndrome: A Prospective Randomized Clinical Trial

High Velocity Nasal Insufflation versus Continuous Positive Airway Pressure as an Initial Respiratory Support in Preterm Neonates with Respiratory Distress Syndrome: A Prospective Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202511465374837
Enrollment
300
Registered
2025-11-11
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Neonatal Diseases

Interventions

Sponsors

Faculty of Medicine Menoufia University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preterm neonates (<37 weeks) of both sexes 2. Neonates diagnosed with respiratory distress syndrome clinically and radiologically. a) Clinical respiratory distress was defined as respiratory effort within the first 24 hours after birth, characterized by at least two of the following: tachypnea, chest retraction, grunting, or cyanosis. b) Radologically diagnosed by chest X-ray findings include fine homogeneous ground glass shadowing, bilateral widespread air bronchogram, confluent alveolar shadowing obscuring the cardiac border, and white lung.

Exclusion criteria

Exclusion criteria: (1) Neonates requiring intubation in the delivery room and invasive mechanical ventilation within the first 24 hours (2) Congenital anomalies where CPAP and Hi-VNI are contraindicated (such as choanal atresia, tracheoesophageal fistula, congenital diaphragmatic hernia, gastroschisis) (3) Neonates transferred to other NICUs during management.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy and safety of High Velocity Nasal Insufflation Hi-VNI compared to nasal Continuous Positive Airway Pressure CPAP as an initial respiratory support in preterm neonates with Respiratory Distress Syndrome

Secondary

MeasureTime frame
To evaluate the other clinical outcomes as well as complications associated with the use of the intervention.

Countries

Egypt

Contacts

Public ContactMohamed Abdelkader Alkenawy

Neonatology resident

MohamedAlkyad@gmail.com+01096139351

Outcome results

None listed

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