Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Avoid of Invasive Mechanical Ventilation in the next three days.
Study Overview
Brief Summary
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
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%).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Minute to 3 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Avoid of Invasive Mechanical Ventilation in the next three days.
Time Frame: through study completion, an average of 1 year
The rate of infants treated with non-invasisive ventilation that do not need to be intubated in the next three days.
Secondary Outcomes
- Time on MV(through study completion, an average of 1 year)
- Neurological impairment(through study completion, an average of 1 year)
- Rate of patients with air leaks(through study completion, an average of 1 year)
Investigators
Manuel Sanchez Luna
Dr.
Hospital General Universitario Gregorio Marañon