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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Pontificia Universidad Catolica de Chile
Sponsor:
Information provided by (Responsible Party):
Alberto Estay, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01778829
First received: January 24, 2013
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Neonatal Respiratory Failure
Procedure: CPAP ventilation mode
Procedure: NIPPV ventilation mode
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Extubation failure [ Time Frame: apnea rate and respiratory failure. ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 220
Study Start Date: December 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778829

Contacts
Contact: Alberto Estay, MD 56223546437 albertoestay@gmail.com
Contact: Alvaro Gonzalez, MD

Locations
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
Principal Investigator: Alberto Estay, MD Pontificia Universidad Catolica de Chile
  More Information

No publications provided

Responsible Party: Alberto Estay, MD, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01778829     History of Changes
Other Study ID Numbers: Sa10i20033
Study First Received: January 24, 2013
Last Updated: January 28, 2013
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Additional relevant MeSH terms:
Birth Weight
Respiratory Insufficiency
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014