Early CPAP in Respiratory Distress Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-09-30

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome

Keywords

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Respiratory Distress Syndrome Early Bubble CPAP Mechanical Ventilation Surfactant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Early Bubble CPAP

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

5 Minutes

Maximum Eligible Age

30 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pontificia Universidad Catolica

Principal Investigators

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José Luis Tapia, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Católica

Aldo Bancalari, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Guillermo Grant

Soledad Urzua, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Católica

Locations

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Servicio de Neonatología, Hospital de Clínicas José de San Martín

Buenos Aires, , Argentina

Site Status RECRUITING

Servicio de Neonatología, Hospital Fernández

Buenos Aires, , Argentina

Site Status RECRUITING

Servicio de Neonatología, Hospital Italiano

Buenos Aires, , Argentina

Site Status RECRUITING

Servicio de Neonatología, Maternidad Sardá

Buenos Aires, , Argentina

Site Status RECRUITING

Servicio de Neonatología, Hospital Lagomaggiore

Mendoza, , Argentina

Site Status RECRUITING

Servicio de Neonatología, Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

Site Status SUSPENDED

Servicio de Neonatología, Hospital Guillermo Grant

Concepción, Región del Biobío, Chile

Site Status RECRUITING

Servicio de Neonatología, Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Servicio de Neonatología, Hospital San José

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Servicio de Neonatología, Hospital Sótero del Rio

Santiago, Santiago Metropolitan, Chile

Site Status NOT_YET_RECRUITING

Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción

Asunción, , Paraguay

Site Status NOT_YET_RECRUITING

Servicio de Neonatología, Hospital Cayetano Heredia

Lima, , Peru

Site Status RECRUITING

Servicio de neonatología, Centro Hospitalario Pereira Rosseli

Montevideo, , Uruguay

Site Status NOT_YET_RECRUITING

Countries

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Argentina Chile Paraguay Peru Uruguay

Central Contacts

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José Luis Tapia, MD

Role: CONTACT

Phone: 56-2-3546437

Email: [email protected]

Soledad Urzua, MD

Role: CONTACT

Phone: 56-2-3543348

Email: [email protected]

Facility Contacts

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Isabel Kurlat

Role: primary

Liliana Roldan, MD

Role: primary

Gonzalo Mariani, MD

Role: primary

Carlos Grandi, MD

Role: primary

Javier Meritano, MD

Role: backup

Augusto Fischetti, MD

Role: primary

Aldo Bancalari, MD

Role: primary

Jaime Burgos, MD

Role: primary

Agustina Gonzalez, MD

Role: primary

Patricia Mena, MD

Role: primary

Soledad Urzúa, MD

Role: primary

José Luis Tapia, MD

Role: backup

José Lacarruba, MD

Role: primary

Elizabeth Cespedes, MD

Role: backup

Jaime Zegarra, MD

Role: primary

Fabiola Rivera, MD

Role: backup

Ruben Panizza, MD

Role: primary

References

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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. doi: 10.1038/sj.jp.7210904.

Reference Type BACKGROUND

PMID: 12732855 (View on PubMed)

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. doi: 10.1056/NEJM197106172842401. No abstract available.

Reference Type BACKGROUND

PMID: 4930602 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 1097619 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 326199 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 6780266 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8477167 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10393390 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8839743 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10835057 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10430740 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9925870 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12076463 (View on PubMed)

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. doi: 10.1002/14651858.CD001243.pub2.

Reference Type BACKGROUND

PMID: 16034858 (View on PubMed)

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. doi: 10.1159/000013962.

Reference Type BACKGROUND

PMID: 9483299 (View on PubMed)

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. doi: 10.1046/j.1440-1754.2001.00624.x.

Reference Type BACKGROUND

PMID: 11328472 (View on PubMed)

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. doi: 10.1016/j.jpeds.2011.12.054. Epub 2012 Mar 6.

Reference Type DERIVED

PMID: 22402568 (View on PubMed)

Other Identifiers

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NEO032006

Identifier Type: -

Identifier Source: org_study_id

Early CPAP in Respiratory Distress Syndrome

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Early Bubble CPAP

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pontificia Universidad Catolica de Chile

Responsible Party

Principal Investigators

José Luis Tapia, MD

Aldo Bancalari, MD

Soledad Urzua, MD

Locations

Servicio de Neonatología, Hospital de Clínicas José de San Martín

Servicio de Neonatología, Hospital Fernández

Servicio de Neonatología, Hospital Italiano

Servicio de Neonatología, Maternidad Sardá

Servicio de Neonatología, Hospital Lagomaggiore

Servicio de Neonatología, Hospital Gustavo Fricke

Servicio de Neonatología, Hospital Guillermo Grant

Servicio de Neonatología, Hospital Clínico Universidad de Chile

Servicio de Neonatología, Hospital San José

Servicio de Neonatología, Hospital Sótero del Rio

Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica

Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción

Servicio de Neonatología, Hospital Cayetano Heredia

Servicio de neonatología, Centro Hospitalario Pereira Rosseli

Countries

Central Contacts

José Luis Tapia, MD

Soledad Urzua, MD

Facility Contacts

Isabel Kurlat

Liliana Roldan, MD

Gonzalo Mariani, MD

Carlos Grandi, MD

Javier Meritano, MD

Augusto Fischetti, MD

Aldo Bancalari, MD

Jaime Burgos, MD

Agustina Gonzalez, MD

Patricia Mena, MD

Soledad Urzúa, MD

José Luis Tapia, MD

José Lacarruba, MD

Elizabeth Cespedes, MD

Jaime Zegarra, MD

Fabiola Rivera, MD

Ruben Panizza, MD

References

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. doi: 10.1038/sj.jp.7210904.

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. doi: 10.1056/NEJM197106172842401. 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. doi: 10.1016/s0022-3476(75)80599-3.

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.

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.

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.

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.

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.

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.

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.

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. doi: 10.1002/14651858.CD001243.pub2.

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. doi: 10.1159/000013962.

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. doi: 10.1046/j.1440-1754.2001.00624.x.

Other Identifiers

NEO032006