Skip to main content
Clinical Trials/NCT02628821
NCT02628821
Completed
Not Applicable

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

Hospital General Universitario Gregorio Marañon1 site in 1 country45 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Noninvasive Ventilation
Sponsor
Hospital General Universitario Gregorio Marañon
Enrollment
45
Locations
1
Primary Endpoint
Avoid of Invasive Mechanical Ventilation in the next three days.
Status
Completed
Last Updated
4 years ago

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%).

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2014
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital General Universitario Gregorio Marañon
Responsible Party
Principal Investigator
Principal Investigator

Manuel Sanchez Luna

Dr.

Hospital General Universitario Gregorio Marañon

Eligibility Criteria

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)

Study Sites (1)

Loading locations...

Similar Trials