Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Airway Pressure Durante la Somministrazione Del Surfattante Con Tecnica LISA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Distress Syndrome, Newborn
- Sponsor
- University of Florence
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- Surfactant or mechanical ventilation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Carlo Dani
Full Professor of Pediatrics
University of Florence
Eligibility Criteria
Inclusion Criteria
- •-Infants with gestational age between 25+0 and 31+6 gestational weeks,
- •-RDS which does not require MV
- •-Treatment with NCPAP and FiO2 \>0.30 within the first 6 hours of life,
- •-First dose of caffeine administered
Exclusion Criteria
- •-absence of informed consent,
- •-major congenital malformations,
- •-hydrops fetalis,
- •-chromosomal diseases,
- •-previous treatment with surfactant,
- •-cardiorespiratory instability requiring treatment with vasoactive drugs,
- •-pneumothorax,
- •-death within 72 hours of life.
Outcomes
Primary Outcomes
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
Need for a second dose of surfactant or mechanical ventilation
Secondary Outcomes
- Mechanical ventilation(Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks)
- Noninvasive ventilation(Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks)
- Bronchopulmonary dysplasia(Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks)