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

NCT01778829 | Unknown Phase 3 DMC

• 1 other identifier: Sa10i20033
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

CPAP ventilation mode

ACTIVE COMPARATOR

Once the patient is extubated, CPAP ventilation mode is inmediately administered in order to prevent reintubation

Procedure: CPAP ventilation mode

NIPPV ventilation mode

EXPERIMENTAL

NIPPV: Non Invasive Ventilation mode is administered inmediately after extubation to prevent reintubation

Procedure: NIPPV ventilation mode

Interventions

CPAP ventilation mode PROCEDURE

Patients are ventilated through a nasal prong coneected to a ventilator that provides a continuous positive airway pressure

CPAP ventilation mode

NIPPV ventilation mode PROCEDURE

Patients are ventilated through a nasal prong connected to a ventilator that provides a non synchronized intermittent positive pressure ventilation

NIPPV ventilation mode

Eligibility Criteria

• Age: 2 Hours - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico, Pontificia Universidad Catolica de Chile

Santiago, Chile

RECRUITING

Related Publications (1)

• Estay AS, Mariani GL, Alvarez CA, Milet B, Agost D, Avila CP, Roldan L, Abdala DA, Keller R, Galletti MF, Gonzalez A; for the NEOCOSUR Neonatal Network. Randomized Controlled Trial of Nonsynchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal CPAP after Extubation of VLBW Infants. Neonatology. 2020;117(2):193-199. doi: 10.1159/000506164. Epub 2020 May 8.

  PMID: 32388511 DERIVED

Study Officials

• Alberto Estay, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Estay, MD

CONTACT

56223546437; albertoestay@gmail.com

Alvaro Gonzalez, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 29, 2013
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

CL (1)