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%).
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Madrid, Spania, 28033
- Cristina Ramos-Navarro
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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%).
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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%). |
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Avoid of Invasive Mechanical Ventilation in the next three days.
Tidsramme: 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.
|
through study completion, an average of 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time on MV
Tidsramme: through study completion, an average of 1 year
|
Days on MV during hospitalitation
|
through study completion, an average of 1 year
|
|
Neurological impairment
Tidsramme: 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
|
|
Rate of patients with air leaks
Tidsramme: through study completion, an average of 1 year
|
pulmonary air leak
|
through study completion, an average of 1 year
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Cristina Ramos-Navarro, Gregorio Maranon Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 02/2015
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