The Effectiveness of Non-Invasive Ventilation Use in Preterm Infants.

Study Overview
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Brief Summary
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Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well as respiratory outcomes and possible secondary side effects. SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).

Detailed Description
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SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%).

Official Title
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Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.

Conditions
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Noninvasive Ventilation, Preterm Infants

Intervention / Treatment
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* Other: Preterm Infants treated with non-invasive ventilation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied for nCPAP failure. Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied electively for extubation. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 3 Months

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm Infants treated with non-invasive ventilation<br>Preterm Infants of less than 32 weeks of Gestational age treated with synchronized non-invasive ventilation (SNIPPV) to prevent intubation or extubation failure based in a prospective protocol: nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria if they are in a stable situation. Electively For extubation: Preterm infants in which nCPAP extubation has previously failed or Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP > 10 cmH2O and FiO2>35%). | Other: Preterm Infants treated with non-invasive ventilation.<br> <br> * Other names: (Giulia®, Neonatal Nasal Ventilator);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Avoid of Invasive Mechanical Ventilation in the next three days. | The rate of infants treated with non-invasisive ventilation that do not need to be intubated in the next three days. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on MV | Days on MV during hospitalitation | through study completion, an average of 1 year | 
| Neurological impairment | Intraventricular hemorrhage grade 3 or 4 (papile´s classification) | through study completion, an average of 1 year | 
| Rate of patients with air leaks | pulmonary air leak | through study completion, an average of 1 year |