Early CPAP in Respiratory Distress Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Pontificia Universidad Catolica de Chile.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT00368680
First received: August 24, 2006
Last updated: December 23, 2010
Last verified: April 2007
  Purpose

The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.


Condition Intervention Phase
Respiratory Distress Syndrome
Device: Early Bubble CPAP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Need for mechanical ventilation

Secondary Outcome Measures:
  • Days of oxygen therapy
  • Days of mechanical ventilation
  • Need for surfactant
  • Pulmonary airleak
  • Intraventricular hemorrhage
  • Persistent ductus arteriosus
  • retinopathy of prematurity
  • Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.

Estimated Enrollment: 256
Study Start Date: January 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation.

Hypothesis:

- The hypothesis is that EBCPAP will decrease the need for this more invasive therapy.

The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. .

As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.

Comparison(s):

Early Bubble CPAP (EBCPAP)with Standard Therapy which is oxygen.

  Eligibility

Ages Eligible for Study:   up to 30 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All infants born at the units belonging to the South American Neocosur Network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with Neopuff or transient intubation are eligible.
  • An informed consent form should be obtained preferable prenatal.

Exclusion Criteria:

  • Acute life threatening congenital malformations or genetics diseases.
  • Apgar score equal or less than 3 at 5 minutes
  • Disapproval of informed consent.
  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: NCT00368680

Contacts
Contact: José Luis Tapia, MD 56-2-3546437 jlta@med.puc.cl
Contact: Soledad Urzua, MD 56-2-3543348 soleurzua@gmail.com

Locations
Argentina
Servicio de Neonatología, Hospital de Clínicas José de San Martín Recruiting
Buenos Aires, Argentina
Contact: Isabel Kurlat       ikurlat@hospitaldeclinicas.uba.ar   
Sub-Investigator: Isabel Kurlat, MD         
Servicio de Neonatología, Hospital Italiano Recruiting
Buenos Aires, Argentina
Contact: Gonzalo Mariani, MD       gonzalo.mariani@hospitalitaliano.org.ar   
Sub-Investigator: Gonzalo Mariani, MD         
Servicio de Neonatología, Hospital Fernández Recruiting
Buenos Aires, Argentina
Contact: Liliana Roldan, MD       liedro@gmail.com   
Sub-Investigator: Liliana Roldan, MD         
Servicio de Neonatología, Maternidad Sardá Recruiting
Buenos Aires, Argentina
Contact: Carlos Grandi, MD       cgrandi@intramed.net   
Contact: Javier Meritano, MD       jmeritano@gmail.com   
Sub-Investigator: Carlos Grandi, MD         
Servicio de Neonatología, Hospital Lagomaggiore Recruiting
Mendoza, Argentina
Contact: Augusto Fischetti, MD       afischetti@supernet.com.ar   
Sub-Investigator: Augusto Fischetti, MD         
Chile
Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica Recruiting
Santiago, Región Metropolitana, Chile
Contact: Soledad Urzúa, MD    56-2-3543348    soleurzua@gmail.com   
Contact: José Luis Tapia, MD    56-2-3546437    jlta@med.puc.cl   
Principal Investigator: Soledad Urzúa, MD         
Servicio de Neonatología, Hospital San José Not yet recruiting
Santiago, Región Metropolitana, Chile
Contact: Agustina Gonzalez, MD    56-2-3832600 ext 2731    tinigonzalez3@yahoo.es   
Sub-Investigator: Agustina Gonzalez, MD         
Servicio de Neonatología, Hospital Sótero del Rio Not yet recruiting
Santiago, Región Metropolitana, Chile
Contact: Patricia Mena, MD    56-2-3536000 ext 6535    pmena@uec.uchile.cl   
Sub-Investigator: Patricia Mena, MD         
Servicio de Neonatología, Hospital Clínico Universidad de Chile Recruiting
Santiago, Región Metropolitana, Chile
Contact: Jaime Burgos, MD       jfburgosm@hotmail.com   
Sub-Investigator: Jaime Burgos, MD         
Servicio de Neonatología, Hospital Gustavo Fricke Suspended
Viña del Mar, V Región, Chile
Servicio de Neonatología, Hospital Guillermo Grant Recruiting
Concepción, VIII Región, Chile
Contact: Aldo Bancalari, MD       abancalari@entelchile.net   
Principal Investigator: Aldo Bancalari, MD         
Paraguay
Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción Not yet recruiting
Asuncion, Paraguay
Contact: José Lacarruba, MD       laca@conexion.com.py   
Contact: Elizabeth Cespedes, MD       elizabethcespedes@yahoo.com.ar   
Sub-Investigator: José Lacarruba, MD         
Peru
Servicio de Neonatología, Hospital Cayetano Heredia Recruiting
Lima, Peru
Contact: Jaime Zegarra, MD       zegpach@upch.edu.pe   
Contact: Fabiola Rivera, MD       fabiolariveraab@yahoo.com   
Sub-Investigator: Jaime Zegarra, MD         
Uruguay
Servicio de neonatología, Centro Hospitalario Pereira Rosseli Not yet recruiting
Montevideo, Uruguay
Contact: Ruben Panizza, MD       rubenpanizza@montevideo.com.uy   
Sub-Investigator: Ruben Panizza, MD         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: José Luis Tapia, MD Pontificia Universidad Católica
Principal Investigator: Aldo Bancalari, MD Hospital Guillermo Grant
Principal Investigator: Soledad Urzua, MD Pontificia Universidad Católica
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neonatologia, Hospital Clinico, Pontificia Universidad Catolica
ClinicalTrials.gov Identifier: NCT00368680     History of Changes
Other Study ID Numbers: NEO032006
Study First Received: August 24, 2006
Last Updated: December 23, 2010
Health Authority: Chile: Ministerio de Salud, Servicio de Salud Metropolitano Sur-Oriente y Norte

Keywords provided by Pontificia Universidad Catolica de Chile:
Respiratory Distress Syndrome
Early Bubble CPAP
Mechanical Ventilation
Surfactant

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 15, 2014