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

August 23, 2021 updated by: Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon

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%).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%).

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28033
        • Cristina Ramos-Navarro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:

  • nCPAP failure: Preterm infants supported with nCPAP that meet intubation criteria if they are in a stable situation.
  • 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%).
Other: Preterm Infants treated with non-invasive ventilation.
Other Names:
  • (Giulia®, Neonatal Nasal Ventilator)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Avoid of Invasive Mechanical Ventilation in the next three days.
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time on MV
Time Frame: through study completion, an average of 1 year
Days on MV during hospitalitation
through study completion, an average of 1 year
Neurological impairment
Time Frame: 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
Time Frame: through study completion, an average of 1 year
pulmonary air leak
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Investigators

  • Principal Investigator: Cristina Ramos-Navarro, Gregorio Marañon hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Infants

Clinical Trials on Preterm Infants treated with non-invasive ventilation.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe