Non Invasive Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants. (VNINS)

January 28, 2013 updated by: Alberto Estay, Pontificia Universidad Catolica de Chile

Nasal Intermittent Mandatory Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants of the NEOCOSUR Network.

The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Is a Randomized trial to preterms infants <1500g and less than 34 weeks with RDS requiring machanical ventilation in the extubation period, randomized to receive NIPPV or NCPAP once extubation criteria were met. Parental written informed consent is required previous extubation. The failure rate is defined as the need for re-intubation and mechanical ventilation).

Exclusion criteria are: major congenital anomalies; presence of cardiovascular instability;intubation less than 2 hours; mechanical ventilation more than 14 days, using muscle relaxant, airway anomalies, consent not provided or refused.

Outcome measures:

The primary outcome was to assess the need for re-intubation within the first 72 hours after extubation in the 2 groups.

The criteria for failure were met by at least 1 of the following:

pH < 7.25 and PaCO2 > 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 < 50 mm Hg with a fraction of inspired oxygen > 0.6. The secondary outcomes concerning respiratory support were total duration on ETT ventilation, total duration on NCPAP, total duration on supplemental oxygen, incidence of pneumothorax,BPD and dead. Other outcomes included incidence of patent ductus arteriosus (PDA), necrotizing enterocolitis, intraventricular hemorrhage grades 3 and 4, retinopathy of prematurity stage 3, time to full feeds, and length of hospital stay.

Sample size calculations for the primary outcome: We estimated that there would be a more than 80% chance of detecting 43% difference between the groups (alpha 0.05) when samplesize (n) is 110 patients for each mode of treatment.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 3

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

  • Chile
      • Santiago, Chile
        • Recruiting
        • Hospital Clinico, Pontificia Universidad Catolica de Chile
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alberto Estay, MD

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

2 hours to 2 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm with a weight less than 1501 g
  • Gestational age less or equal to 34 weeks
  • Preterm that meets extubation criteria after at least 2 hours and less than 14 days connected to mechanical ventilation
  • Patient receiving methylxanthynes

Exclusion Criteria:

  • Patient more than 14 days in mechanical ventilation
  • Newborn with congenital cardiopathy
  • Newborn with congenital malformation
  • Newborn wirh chromosomopathy or genopathic disease
  • Newborn with suspected gastrointestinal disease
  • Newborn with neuromuscular disease or receiving muscle relaxants
  • Lack or informed consent signed by parents or legal representative

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CPAP ventilation mode
Once the patient is extubated, CPAP ventilation mode is inmediately administered in order to prevent reintubation
Procedure: CPAP ventilation mode
Patients are ventilated through a nasal prong coneected to a ventilator that provides a continuous positive airway pressure
EXPERIMENTAL: NIPPV ventilation mode
NIPPV: Non Invasive Ventilation mode is administered inmediately after extubation to prevent reintubation
Procedure: NIPPV ventilation mode
Patients are ventilated through a nasal prong connected to a ventilator that provides a non synchronized intermittent positive pressure ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation failure
Time Frame: apnea rate and respiratory failure.

The criteria for failure were met by at least 1 of the following:

pH less than 7.25 and PaCO2 over 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 less than 50 mm Hg with a fraction of inspired oxygen over 0.6.
apnea rate and respiratory failure.

Collaborators and Investigators

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

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Alberto Estay, MD, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2011

Primary Completion (ANTICIPATED)

May 1, 2013

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

January 24, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (ESTIMATE)

January 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sa10i20033

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.

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