NCT00368680

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2007

Typical duration for phase_4

Geographic Reach
5 countries

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 24, 2010

Status Verified

April 1, 2007

Enrollment Period

1.2 years

First QC Date

August 24, 2006

Last Update Submit

December 23, 2010

Conditions

Respiratory Distress Syndrome

Keywords

Respiratory Distress SyndromeEarly Bubble CPAPMechanical VentilationSurfactant

Outcome Measures

Primary Outcomes (1)

  • Need for mechanical ventilation

Secondary Outcomes (8)

  • Days of oxygen therapy

  • Days of mechanical ventilation

  • Need for surfactant

  • Pulmonary airleak

  • Intraventricular hemorrhage

  • +3 more secondary outcomes

Interventions

Early Bubble CPAPDEVICE

Eligibility Criteria

Age5 Minutes - 30 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Acute life threatening congenital malformations or genetics diseases.
  • Apgar score equal or less than 3 at 5 minutes
  • Disapproval of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Servicio de Neonatología, Hospital de Clínicas José de San Martín

Buenos Aires, Argentina

RECRUITING

Servicio de Neonatología, Hospital Fernández

Buenos Aires, Argentina

RECRUITING

Servicio de Neonatología, Hospital Italiano

Buenos Aires, Argentina

RECRUITING

Servicio de Neonatología, Maternidad Sardá

Buenos Aires, Argentina

RECRUITING

Servicio de Neonatología, Hospital Lagomaggiore

Mendoza, Argentina

RECRUITING

Servicio de Neonatología, Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

SUSPENDED

Servicio de Neonatología, Hospital Guillermo Grant

Concepción, Región del Biobío, Chile

RECRUITING

Servicio de Neonatología, Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

RECRUITING

Servicio de Neonatología, Hospital San José

Santiago, Santiago Metropolitan, Chile

NOT YET RECRUITING

Servicio de Neonatología, Hospital Sótero del Rio

Santiago, Santiago Metropolitan, Chile

NOT YET RECRUITING

Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica

Santiago, Santiago Metropolitan, Chile

RECRUITING

Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción

Asunción, Paraguay

NOT YET RECRUITING

Servicio de Neonatología, Hospital Cayetano Heredia

Lima, Peru

RECRUITING

Servicio de neonatología, Centro Hospitalario Pereira Rosseli

Montevideo, Uruguay

NOT YET RECRUITING

Related Publications (16)

  • 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.

    PMID: 4930602BACKGROUND

  • 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.

    PMID: 1097619BACKGROUND

  • 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.

    PMID: 326199BACKGROUND

  • 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.

    PMID: 6780266BACKGROUND

  • 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.

    PMID: 8477167BACKGROUND

  • 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.

    PMID: 10393390BACKGROUND

  • 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.

    PMID: 8839743BACKGROUND

  • 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.

    PMID: 10835057BACKGROUND

  • 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.

    PMID: 10430740BACKGROUND

  • 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.

    PMID: 9925870BACKGROUND

  • 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.

    PMID: 12076463BACKGROUND

  • 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.

    PMID: 16034858BACKGROUND

  • 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.

    PMID: 9483299BACKGROUND

  • 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.

    PMID: 11328472BACKGROUND

  • 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.

    PMID: 12732855BACKGROUND

  • 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.

    PMID: 22402568DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • José Luis Tapia, MD

    Pontificia Universidad Católica

    PRINCIPAL INVESTIGATOR

  • Aldo Bancalari, MD

    Hospital Guillermo Grant

    PRINCIPAL INVESTIGATOR

  • Soledad Urzua, MD

    Pontificia Universidad Católica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José Luis Tapia, MD

CONTACT

56-2-3546437jlta@med.puc.cl

Soledad Urzua, MD

CONTACT

56-2-3543348soleurzua@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 25, 2006

Study Start

January 1, 2007

Primary Completion

April 1, 2008

Study Completion

September 1, 2009

Last Updated

December 24, 2010

Record last verified: 2007-04

Locations

CL(6)PE(1)PA(1)AR(5)UR(1)