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Early CPAP in Respiratory Distress Syndrome

Primary Purpose

Respiratory Distress Syndrome

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Early Bubble CPAP
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring Respiratory Distress Syndrome, Early Bubble CPAP, Mechanical Ventilation, Surfactant

Eligibility Criteria

5 Minutes - 30 Minutes (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Servicio de Neonatología, Hospital de Clínicas José de San MartínRecruiting
  • Servicio de Neonatología, Hospital FernándezRecruiting
  • Servicio de Neonatología, Hospital ItalianoRecruiting
  • Servicio de Neonatología, Maternidad SardáRecruiting
  • Servicio de Neonatología, Hospital LagomaggioreRecruiting
  • Servicio de Neonatología, Hospital Clínico Universidad de ChileRecruiting
  • Servicio de Neonatología, Hospital San José
  • Servicio de Neonatología, Hospital Sótero del Rio
  • Unidad de Neonatología, Hospital Clínico Pontificia Universidad CatólicaRecruiting
  • Servicio de Neonatología, Hospital Gustavo Fricke
  • Servicio de Neonatología, Hospital Guillermo GrantRecruiting
  • Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción
  • Servicio de Neonatología, Hospital Cayetano HerediaRecruiting
  • Servicio de neonatología, Centro Hospitalario Pereira Rosseli

Outcomes

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.

Full Information

First Posted
August 24, 2006
Last Updated
December 23, 2010
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT00368680
Brief Title
Early CPAP in Respiratory Distress Syndrome
Official Title
Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2008 (undefined)
Study Completion Date
September 2009 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Respiratory Distress Syndrome, Early Bubble CPAP, Mechanical Ventilation, Surfactant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Early Bubble CPAP
Primary Outcome Measure Information:
Title
Need for mechanical ventilation
Secondary Outcome Measure Information:
Title
Days of oxygen therapy
Title
Days of mechanical ventilation
Title
Need for surfactant
Title
Pulmonary airleak
Title
Intraventricular hemorrhage
Title
Persistent ductus arteriosus
Title
retinopathy of prematurity
Title
Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Minutes
Maximum Age & Unit of Time
30 Minutes
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Luis Tapia, MD
Phone
56-2-3546437
Email
jlta@med.puc.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Soledad Urzua, MD
Phone
56-2-3543348
Email
soleurzua@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Luis Tapia, MD
Organizational Affiliation
Pontificia Universidad Católica
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aldo Bancalari, MD
Organizational Affiliation
Hospital Guillermo Grant
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soledad Urzua, MD
Organizational Affiliation
Pontificia Universidad Católica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Servicio de Neonatología, Hospital de Clínicas José de San Martín
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Kurlat
Email
ikurlat@hospitaldeclinicas.uba.ar
First Name & Middle Initial & Last Name & Degree
Isabel Kurlat, MD
Facility Name
Servicio de Neonatología, Hospital Fernández
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliana Roldan, MD
Email
liedro@gmail.com
First Name & Middle Initial & Last Name & Degree
Liliana Roldan, MD
Facility Name
Servicio de Neonatología, Hospital Italiano
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonzalo Mariani, MD
Email
gonzalo.mariani@hospitalitaliano.org.ar
First Name & Middle Initial & Last Name & Degree
Gonzalo Mariani, MD
Facility Name
Servicio de Neonatología, Maternidad Sardá
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Grandi, MD
Email
cgrandi@intramed.net
First Name & Middle Initial & Last Name & Degree
Javier Meritano, MD
Email
jmeritano@gmail.com
First Name & Middle Initial & Last Name & Degree
Carlos Grandi, MD
Facility Name
Servicio de Neonatología, Hospital Lagomaggiore
City
Mendoza
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Augusto Fischetti, MD
Email
afischetti@supernet.com.ar
First Name & Middle Initial & Last Name & Degree
Augusto Fischetti, MD
Facility Name
Servicio de Neonatología, Hospital Clínico Universidad de Chile
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Burgos, MD
Email
jfburgosm@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jaime Burgos, MD
Facility Name
Servicio de Neonatología, Hospital San José
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agustina Gonzalez, MD
Phone
56-2-3832600
Ext
2731
Email
tinigonzalez3@yahoo.es
First Name & Middle Initial & Last Name & Degree
Agustina Gonzalez, MD
Facility Name
Servicio de Neonatología, Hospital Sótero del Rio
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Mena, MD
Phone
56-2-3536000
Ext
6535
Email
pmena@uec.uchile.cl
First Name & Middle Initial & Last Name & Degree
Patricia Mena, MD
Facility Name
Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
City
Santiago
State/Province
Región Metropolitana
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soledad Urzúa, MD
Phone
56-2-3543348
Email
soleurzua@gmail.com
First Name & Middle Initial & Last Name & Degree
José Luis Tapia, MD
Phone
56-2-3546437
Email
jlta@med.puc.cl
First Name & Middle Initial & Last Name & Degree
Soledad Urzúa, MD
Facility Name
Servicio de Neonatología, Hospital Gustavo Fricke
City
Viña del Mar
State/Province
V Región
Country
Chile
Individual Site Status
Suspended
Facility Name
Servicio de Neonatología, Hospital Guillermo Grant
City
Concepción
State/Province
VIII Región
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldo Bancalari, MD
Email
abancalari@entelchile.net
First Name & Middle Initial & Last Name & Degree
Aldo Bancalari, MD
Facility Name
Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción
City
Asuncion
Country
Paraguay
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Lacarruba, MD
Email
laca@conexion.com.py
First Name & Middle Initial & Last Name & Degree
Elizabeth Cespedes, MD
Email
elizabethcespedes@yahoo.com.ar
First Name & Middle Initial & Last Name & Degree
José Lacarruba, MD
Facility Name
Servicio de Neonatología, Hospital Cayetano Heredia
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Zegarra, MD
Email
zegpach@upch.edu.pe
First Name & Middle Initial & Last Name & Degree
Fabiola Rivera, MD
Email
fabiolariveraab@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jaime Zegarra, MD
Facility Name
Servicio de neonatología, Centro Hospitalario Pereira Rosseli
City
Montevideo
Country
Uruguay
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Panizza, MD
Email
rubenpanizza@montevideo.com.uy
First Name & Middle Initial & Last Name & Degree
Ruben Panizza, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
4930602
Citation
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Results Reference
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PubMed Identifier
1097619
Citation
Krouskop RW, Brown EG, Sweet AY. The early use of continuous positive airway pressure in the treatment of idiopathic respiratory distress syndrome. J Pediatr. 1975 Aug;87(2):263-7. doi: 10.1016/s0022-3476(75)80599-3.
Results Reference
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PubMed Identifier
326199
Citation
Allen LP, Reynolds ER, Rivers RP, Le Souef PM, Wimberley PD. Controlled trial of continuous positive airway pressure given by face mask for hyaline membrane disease. Arch Dis Child. 1977 May;52(5):373-8. doi: 10.1136/adc.52.5.373.
Results Reference
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PubMed Identifier
6780266
Citation
Hegyi T, Hiatt IM. The effect of continuous positive airway pressure on the course of respiratory distress syndrome: the benefits on early initiation. Crit Care Med. 1981 Jan;9(1):38-41. doi: 10.1097/00003246-198101000-00009.
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PubMed Identifier
8477167
Citation
Kamper J, Wulff K, Larsen C, Lindequist S. Early treatment with nasal continuous positive airway pressure in very low-birth-weight infants. Acta Paediatr. 1993 Feb;82(2):193-7. doi: 10.1111/j.1651-2227.1993.tb12637.x.
Results Reference
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PubMed Identifier
10393390
Citation
Kamper J. Early nasal continuous positive airway pressure and minimal handling in the treatment of very-low-birth-weight infants. Biol Neonate. 1999 Jun;76 Suppl 1:22-8. doi: 10.1159/000047043.
Results Reference
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PubMed Identifier
8839743
Citation
Lundstrom KE. Initial treatment of preterm infants--continuous positive airway pressure or ventilation? Eur J Pediatr. 1996 Aug;155 Suppl 2:S25-9. doi: 10.1007/BF01958077.
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PubMed Identifier
10835057
Citation
Van Marter LJ, Allred EN, Pagano M, Sanocka U, Parad R, Moore M, Susser M, Paneth N, Leviton A. Do clinical markers of barotrauma and oxygen toxicity explain interhospital variation in rates of chronic lung disease? The Neonatology Committee for the Developmental Network. Pediatrics. 2000 Jun;105(6):1194-201. doi: 10.1542/peds.105.6.1194.
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Michna J, Jobe AH, Ikegami M. Positive end-expiratory pressure preserves surfactant function in preterm lambs. Am J Respir Crit Care Med. 1999 Aug;160(2):634-9. doi: 10.1164/ajrccm.160.2.9902016.
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PubMed Identifier
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Citation
Verder H, Albertsen P, Ebbesen F, Greisen G, Robertson B, Bertelsen A, Agertoft L, Djernes B, Nathan E, Reinholdt J. Nasal continuous positive airway pressure and early surfactant therapy for respiratory distress syndrome in newborns of less than 30 weeks' gestation. Pediatrics. 1999 Feb;103(2):E24. doi: 10.1542/peds.103.2.e24.
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Ho JJ, Henderson-Smart DJ, Davis PG. Early versus delayed initiation of continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;2002(2):CD002975. doi: 10.1002/14651858.CD002975.
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Results Reference
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Links:
URL
http://sistemas.med.puc.cl/Neocosur/ingles/neocosur.asp
Description
South American Neocosur Network

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Early CPAP in Respiratory Distress Syndrome

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