NIPPV vs.nCPAP During LISA Procedure

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Distress Syndrome, Newborn

Intervention / Treatment
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* Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)
* Procedure: Nasal continuous positive airway pressure (NCPAP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Hours
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LISA with NCPAP<br>In this group, infants will receive NCPAP during LISA procedure. | Procedure: Nasal continuous positive airway pressure (NCPAP)<br>* In this group, infants will receive NCPAP during LISA procedure.<br>|
| Experimental: LISA with NIPPV<br>In this group, infants will receive NIPPV during LISA procedure. | Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)<br>* In this group, infants will receive NIPPV during LISA procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surfactant or mechanical ventilation | Need for a second dose of 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noninvasive ventilation | Duration of noninvasive ventilation | Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks | 
| Mechanical ventilation | Duration ofmechanical ventilation | 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 | Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surfactant, LISA procedure, Preterm infant