Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01778829
Recruitment Status : Unknown
Verified January 2013 by Alberto Estay, Pontificia Universidad Catolica de Chile.
Recruitment status was:  Recruiting
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
Alberto Estay, Pontificia Universidad Catolica de Chile

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neonatal Respiratory Failure Procedure: CPAP ventilation mode Procedure: NIPPV ventilation mode Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal Intermittent Mandatory Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants of the NEOCOSUR Network.
Study Start Date : December 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778829


Contacts
Layout table for location contacts
Contact: Alberto Estay, MD 56223546437 albertoestay@gmail.com
Contact: Alvaro Gonzalez, MD

Locations
Layout table for location information
Chile
Hospital Clinico, Pontificia Universidad Catolica de Chile Recruiting
Santiago, Chile
Contact: Alberto Estay, MD       albertoestay@gmail.com   
Contact: Alvaro Gonzalez, MD       alvgonza@med.puc.cl   
Principal Investigator: Alberto Estay, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Layout table for investigator information
Principal Investigator: Alberto Estay, MD Pontificia Universidad Catolica de Chile
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Alberto Estay, MD, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01778829    
Other Study ID Numbers: Sa10i20033
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Birth Weight
Respiration Disorders
Respiratory Tract Diseases
Body Weight