The Effectiveness of Non-Invasive Ventilation Use in Preterm Infants.
Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.
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%).
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Madrid, Spanje, 28033
- Cristina Ramos-Navarro
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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%).
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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:
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%). |
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Avoid of Invasive Mechanical Ventilation in the next three days.
Tijdsspanne: through study completion, an average of 1 year
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The rate of infants treated with non-invasisive ventilation that do not need to be intubated in the next three days.
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through study completion, an average of 1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time on MV
Tijdsspanne: through study completion, an average of 1 year
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Days on MV during hospitalitation
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through study completion, an average of 1 year
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Neurological impairment
Tijdsspanne: through study completion, an average of 1 year
|
Intraventricular hemorrhage grade 3 or 4 (papile´s classification)
|
through study completion, an average of 1 year
|
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Rate of patients with air leaks
Tijdsspanne: through study completion, an average of 1 year
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pulmonary air leak
|
through study completion, an average of 1 year
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Cristina Ramos-Navarro, Gregorio Maranon Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 02/2015
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