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

Preterm Infants Clinical Trial

Official title:

Effectiveness of Synchronized Non-Invasive Ventilation to Prevent Invasive Mechanical Ventilation Use in Preterm Infants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628821
• Other study ID #: 02/2015
• Status: Completed
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2021
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%).

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Noninvasive Ventilation
• Premature Birth
• Preterm Infants

Intervention

Other:
• Preterm Infants treated with non-invasive ventilation.

Locations

Country	Name	City	State
Spain	Cristina Ramos-Navarro	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Avoid of Invasive Mechanical Ventilation in the next three days.	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
Secondary	Time on MV	Days on MV during hospitalitation	through study completion, an average of 1 year
Secondary	Neurological impairment	Intraventricular hemorrhage grade 3 or 4 (papile´s classification)	through study completion, an average of 1 year
Secondary	Rate of patients with air leaks	pulmonary air leak	through study completion, an average of 1 year