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Early CPAP in Respiratory Distress Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Child)
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

Locations
Argentina
Servicio de Neonatología, Hospital de Clínicas José de San Martín
Buenos Aires, Argentina
Servicio de Neonatología, Hospital Fernández
Buenos Aires, Argentina
Servicio de Neonatología, Hospital Italiano
Buenos Aires, Argentina
Servicio de Neonatología, Maternidad Sardá
Buenos Aires, Argentina
Servicio de Neonatología, Hospital Lagomaggiore
Mendoza, Argentina
Chile
Servicio de Neonatología, Hospital Clínico Universidad de Chile
Santiago, Región Metropolitana, Chile
Servicio de Neonatología, Hospital San José
Santiago, Región Metropolitana, Chile
Servicio de Neonatología, Hospital Sótero del Rio
Santiago, Región Metropolitana, Chile
Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
Santiago, Región Metropolitana, Chile
Servicio de Neonatología, Hospital Gustavo Fricke
Viña del Mar, V Región, Chile
Servicio de Neonatología, Hospital Guillermo Grant
Concepción, VIII Región, Chile
Paraguay
Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción
Asuncion, Paraguay
Peru
Servicio de Neonatología, Hospital Cayetano Heredia
Lima, Peru
Uruguay
Servicio de neonatología, Centro Hospitalario Pereira Rosseli
Montevideo, Uruguay
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:

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:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on December 02, 2016