NCT05796128

NIPPV vs.nCPAP During LISA Procedure

Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: University of Florence · Academic / Other
• Sex: All
• Age: 0 Hours – 72 Hours
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants. The main question it aims to answer is: • Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 \>0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
PROCEDURE	Nasal Intermittent Positive Pressure Ventilation (NIPPV)	In this group, infants will receive NIPPV during LISA procedure.
PROCEDURE	Nasal continuous positive airway pressure (NCPAP)	In this group, infants will receive NCPAP during LISA procedure.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-31
• Completion: 2023-01-23
• First posted: 2023-04-03
• Last updated: 2023-04-03

Locations

1 site across 1 country: Italy