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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02628821

Enrollment

Registered

2015-12-11

Start date

2012-01-31

Completion date

2014-12-31

Last updated

2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noninvasive Ventilation, Preterm Infants

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%).

Interventions

OTHERPreterm Infants treated with non-invasive ventilation.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 3 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026