Clinical trial NCT02628821: The Effectiveness of Non-Invasive Ventilation Use in Preterm Infants.
Official title: Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Noninvasive Ventilation
Preterm Infants
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective observational study of SNIPPV use in preterm infants of less than 32 weeks of gestation from January 2012 to December of 2014.

SNIPPV is used for:

* nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria (FiO2\>50%; apnea spells more than 4/h or more than 1 that needs PPV) if they are in a stable situation. SAP (systemic arterial pressure)\> P10 with preserved respiratory drive (no more than 6 apneas episodes per hour or more than 2 requiring PPI).
* 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%).

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%).

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: None

Primary outcomes:
measure: Avoid of Invasive Mechanical Ventilation in the next three days.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Time on MV
timeFrame: through study completion, an average of 1 year
measure: Neurological impairment
timeFrame: through study completion, an average of 1 year
measure: Rate of patients with air leaks
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Cristina Ramos-Navarro
Study officials:
affiliation: Gregorio Marañón Hospital
name: Cristina Ramos-Navarro
role: PRINCIPAL_INVESTIGATOR
References: