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

Neonatal Respiratory Failure Clinical Trial

— VNINS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01778829
• Other study ID #: Sa10i20033
• Status: Recruiting
• Phase: Phase 3
• First received: January 24, 2013
• Last updated: January 28, 2013
• Start date: December 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2013
• Source: Pontificia Universidad Catolica de Chile
• Contact: Alberto Estay, MD
• Phone: 56223546437
• Email: albertoestay[@]gmail.com
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Neonatal Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• CPAP ventilation mode
Patients are ventilated through a nasal prong coneected to a ventilator that provides a continuous positive airway pressure
• NIPPV ventilation mode
Patients are ventilated through a nasal prong connected to a ventilator that provides a non synchronized intermittent positive pressure ventilation

Locations

Country	Name	City	State
Chile	Hospital Clinico, Pontificia Universidad Catolica de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation 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.	Yes