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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

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%).

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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%).

Conditions

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Noninvasive Ventilation Preterm Infants

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm Infants treated with non-invasive ventilation

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%).

Preterm Infants treated with non-invasive ventilation.

Intervention Type OTHER

Interventions

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Preterm Infants treated with non-invasive ventilation.

Intervention Type OTHER

Other Intervention Names

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(Giulia®, Neonatal Nasal Ventilator)

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.

Minimum Eligible Age

1 Minute

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No