Early CPAP in Respiratory Distress Syndrome

Respiratory Distress Syndrome Clinical Trial

Official title:

Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00368680
• Other study ID #: NEO032006
• Status: Recruiting
• Phase: Phase 4
• First received: August 24, 2006
• Last updated: December 23, 2010
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: April 2007
• Source: Pontificia Universidad Catolica de Chile
• Contact: José Luis Tapia, MD
• Phone: 56-2-3546437
• Email: jlta[@]med.puc.cl
• Is FDA regulated: No
• Health authority: Chile: Ministerio de Salud, Servicio de Salud Metropolitano Sur-Oriente y Norte
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: September 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Minutes

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Early Bubble CPAP

Locations

Country	Name	City	State
Argentina	Servicio de Neonatología, Hospital de Clínicas José de San Martín	Buenos Aires
Argentina	Servicio de Neonatología, Hospital Fernández	Buenos Aires
Argentina	Servicio de Neonatología, Hospital Italiano	Buenos Aires
Argentina	Servicio de Neonatología, Maternidad Sardá	Buenos Aires
Argentina	Servicio de Neonatología, Hospital Lagomaggiore	Mendoza
Chile	Servicio de Neonatología, Hospital Guillermo Grant	Concepción	VIII Región
Chile	Servicio de Neonatología, Hospital Clínico Universidad de Chile	Santiago	Región Metropolitana
Chile	Servicio de Neonatología, Hospital San José	Santiago	Región Metropolitana
Chile	Servicio de Neonatología, Hospital Sótero del Rio	Santiago	Región Metropolitana
Chile	Unidad de Neonatología, Hospital Clínico Pontificia Universidad Católica	Santiago	Región Metropolitana
Chile	Servicio de Neonatología, Hospital Gustavo Fricke	Viña del Mar	V Región
Paraguay	Servicio de Neonatología, Hospital de Clinicas Universidad Nacional Asunción	Asuncion
Peru	Servicio de Neonatología, Hospital Cayetano Heredia	Lima
Uruguay	Servicio de neonatología, Centro Hospitalario Pereira Rosseli	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Countries where clinical trial is conducted

Argentina,  Chile,  Paraguay,  Peru,  Uruguay, 

References & Publications (15)

Allen LP, Reynolds ER, Rivers RP, Le Souëf 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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

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

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for mechanical ventilation
Secondary	Days of oxygen therapy
Secondary	Days of mechanical ventilation
Secondary	Need for surfactant
Secondary	Pulmonary airleak
Secondary	Intraventricular hemorrhage
Secondary	Persistent ductus arteriosus
Secondary	retinopathy of prematurity
Secondary	Bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.

External Links

•   South American Neocosur Network