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

Completed

• Conditions: Preterm Infants; Noninvasive Ventilation
• Interventions: Other: Preterm Infants treated with non-invasive ventilation.

• Registration Number: NCT02628821
• Lead Sponsor: Hospital General Universitario Gregorio Marañon

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm Infants treated with non-invasive ventilation	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%).

Primary Outcome Measures

Name	Time	Method
Avoid of Invasive Mechanical Ventilation in the next three days.	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 Outcome Measures

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

Trial Locations

Locations (1)

Cristina Ramos-Navarro; 🇪🇸 Madrid, Spain