Respiratory Distress Syndrome, Newborn
Conditions
Keywords
Surfactant, LISA procedure, Preterm infant
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.
Interventions
In this group, infants will receive NIPPV during LISA procedure.
In this group, infants will receive NCPAP during LISA procedure.
Sponsors
University of Florence
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Hours to 72 Hours
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surfactant or mechanical ventilation | 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
| Measure | Time frame | Description |
|---|---|---|
| Noninvasive ventilation | Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks | Duration of noninvasive ventilation |
| Mechanical ventilation | Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks | Duration ofmechanical ventilation |
| Bronchopulmonary dysplasia | Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks | Frequency of mild, moderate, and severe bronchopulmonary dysplasia |
Countries
Italy
Outcome results
None listed