NCT02259400

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino" · Academic / Other
• Sex: All
• Age: 2 Hours
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• RDS of Prematurity

Interventions

Type	Name	Description
DEVICE	NSIPPV	In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)\< 0.3.
DEVICE	BiPAP	In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 \< 0.3.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2014-10-08
• Last updated: 2015-02-18
• Results posted: 2015-01-28