Early CPAP in Respiratory Distress Syndrome

Phase 4

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT00368680
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2006-08-24
• Study First Submitted QC: 2006-08-24
• Study First Posted: 2006-08-25
• Study Start: 2007-01
• Status Verified: 2007-04
• Primary Completion: 2008-04
• Study Completion: 2009-09
• Last Update Submitted: 2010-12-23
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Need for mechanical ventilation

Secondary Outcome Measures

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

Trial Locations

Locations (14)

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 de Clinicas Universidad Nacional Asunción; 🇵🇾 Asuncion, Paraguay

Servicio de neonatología, Centro Hospitalario Pereira Rosseli; 🇺🇾 Montevideo, Uruguay

Servicio de Neonatología, Hospital Cayetano Heredia; 🇵🇪 Lima, Peru

Servicio de Neonatología, Hospital Gustavo Fricke; 🇨🇱 Viña del Mar, V Región, Chile

Servicio de Neonatología, Hospital Guillermo Grant; 🇨🇱 Concepción, VIII Región, Chile

Servicio de Neonatología, Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Región Metropolitana, Chile

Servicio de Neonatología, Hospital Lagomaggiore; 🇦🇷 Mendoza, Argentina

Servicio de Neonatología, Hospital de Clínicas José de San Martín; 🇦🇷 Buenos Aires, Argentina

Servicio de Neonatología, Maternidad Sardá; 🇦🇷 Buenos Aires, Argentina

Servicio de Neonatología, Hospital Fernández; 🇦🇷 Buenos Aires, Argentina

Servicio de Neonatología, Hospital Italiano; 🇦🇷 Buenos Aires, Argentina