Early CPAP in Respiratory Distress Syndrome - Full Text View

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:

MedlinePlus related topics: Birth Weight

U.S. FDA Resources

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

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:

South American Neocosur Network This link exits the ClinicalTrials.gov site

Publications:

Gregory GA, Kitterman JA, Phibbs RH, Tooley WH, Hamilton WK. Treatment of the idiopathic respiratory-distress syndrome with continuous positive airway pressure. N Engl J Med. 1971 Jun 17;284(24):1333-40. No abstract available.

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.

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.

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.

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.

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. Review.

Lundstrom KE. Initial treatment of preterm infants--continuous positive airway pressure or ventilation? Eur J Pediatr. 1996 Aug;155 Suppl 2:S25-9. Review.

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.

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.

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.

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;(2):CD002975. Review.

Subramaniam P, Henderson-Smart DJ, Davis PG. Prophylactic nasal continuous positive airways pressure for preventing morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001243. Review.

Lee KS, Dunn MS, Fenwick M, Shennan AT. A comparison of underwater bubble continuous positive airway pressure with ventilator-derived continuous positive airway pressure in premature neonates ready for extubation. Biol Neonate. 1998;73(2):69-75.

De Klerk AM, De Klerk RK. Nasal continuous positive airway pressure and outcomes of preterm infants. J Paediatr Child Health. 2001 Apr;37(2):161-7.

Narendran V, Donovan EF, Hoath SB, Akinbi HT, Steichen JJ, Jobe AH. Early bubble CPAP and outcomes in ELBW preterm infants. J Perinatol. 2003 Apr-May;23(3):195-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tapia JL, Urzua S, Bancalari A, Meritano J, Torres G, Fabres J, Toro CA, Rivera F, Cespedes E, Burgos JF, Mariani G, Roldan L, Silvera F, Gonzalez A, Dominguez A; South American Neocosur Network. Randomized trial of early bubble continuous positive airway pressure for very low birth weight infants. J Pediatr. 2012 Jul;161(1):75-80.e1. Epub 2012 Mar 6.

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
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases

Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 19, 2013