NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome) — NIV  

RDS of Prematurity Clinical Trial

Official title: Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).

Clinical Trial Description

A Randomized Control Trial (RCT) conducted in two tertiary level Neonatal Intensive Care Unit (NICU). Ethical approval is needed. Informed and written consent will be obtained prior the delivery from the parents of the babies before the inclusion in the study. All inborn Very Low Birth Weight (VLBW) infants (Birthweight less than 1500 g and Gestational Age < 32 weeks) with signs of RDS, spontaneously breathing and only supported by nasal-Continuous Positive Airway Pressure (NCPAP) in NICU, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies: Nasal Synchronized Intermittent Positive Pressure Ventilation (N-SIPPV) or Bilevel Continuous Positive Airway Pressure (BiPAP). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• RDS of Prematurity
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

• NCT number: NCT02259400
• Study type: Interventional
• Source: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2010
• Completion date: December 2012