Clinical trial NCT00368680: Early CPAP in Respiratory Distress Syndrome
Official title: Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Respiratory Distress Syndrome
Keywords: Respiratory Distress Syndrome
Early Bubble CPAP
Mechanical Ventilation
Surfactant
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2006-08-25
Enrollment: 256
Sex: ALL
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Need for mechanical ventilation
Secondary outcomes:
measure: Days of oxygen therapy
measure: Days of mechanical ventilation
measure: Need for surfactant
measure: Pulmonary airleak
measure: Intraventricular hemorrhage
measure: Persistent ductus arteriosus
measure: retinopathy of prematurity
measure: Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Servicio de Neonatología, Hospital de Clínicas José de San Martín
city: Buenos Aires
country: Argentina
facility: Servicio de Neonatología, Hospital Fernández
city: Buenos Aires
country: Argentina
facility: Servicio de Neonatología, Hospital Italiano
city: Buenos Aires
country: Argentina
facility: Servicio de Neonatología, Maternidad Sardá
city: Mendoza
country: Argentina
facility: Servicio de Neonatología, Hospital Lagomaggiore
city: Santiago
country: Chile
facility: Servicio de Neonatología, Hospital Clínico Universidad de Chile
state: Región Metropolitana
city: Santiago
country: Chile
facility: Servicio de Neonatología, Hospital San José
state: Región Metropolitana
city: Santiago
country: Chile
facility: Servicio de Neonatología, Hospital Sótero del Rio
state: Región Metropolitana
city: Santiago
country: Chile
facility: Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica
state: Región Metropolitana
city: Viña del Mar
country: Chile
facility: Servicio de Neonatología, Hospital Gustavo Fricke
state: V Región
city: Concepción
country: Chile
facility: Servicio de Neonatología, Hospital Guillermo Grant
state: VIII Región
city: Asuncion
country: Paraguay
facility: Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción
city: Lima
country: Peru
facility: Servicio de Neonatología, Hospital Cayetano Heredia
city: Montevideo
country: Uruguay
facility: Servicio de neonatología, Centro Hospitalario Pereira Rosseli
Study officials:
affiliation: Pontificia Universidad Católica
name: José Luis Tapia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Guillermo Grant
name: Aldo Bancalari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Católica
name: Soledad Urzua, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.