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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
202
In this group, infants will receive NIPPV during LISA procedure.
In this group, infants will receive NCPAP during LISA procedure.
Careggi University Hospital, Division of Neonatology
Florence, Italy
Surfactant or mechanical ventilation
Need for a second dose of surfactant or mechanical ventilation
Time frame: The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life
Noninvasive ventilation
Duration of noninvasive ventilation
Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Mechanical ventilation
Duration ofmechanical ventilation
Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
Bronchopulmonary dysplasia
Frequency of mild, moderate, and severe bronchopulmonary dysplasia
Time frame: Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks
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