At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT
In Brief
A Phase 3 clinical trial evaluating NSIPPV and BiPAP for RDS of Prematurity. Completed, enrolled 280 participants.
Detailed 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).
Study Details
Timeline
Interventions
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.
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.