Early CPAP in Respiratory Distress Syndrome

Overview

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.

Full Title of Study: “Early Bubble CPAP (EBCPAP) in Very Low Birth Weight Infants (VLBWI)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2008

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.

Interventions

  • Device: Early Bubble CPAP

Clinical Trial Outcome Measures

Primary Measures

  • Need for mechanical ventilation

Secondary 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 30 Minutes

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pontificia Universidad Catolica de Chile
  • Provider of Information About this Clinical Study
    • Neonatologia, Hospital Clinico, Pontificia Universidad Catolica
  • Overall Official(s)
    • José Luis Tapia, MD, Principal Investigator, Pontificia Universidad Católica
    • Aldo Bancalari, MD, Principal Investigator, Hospital Guillermo Grant
    • Soledad Urzua, MD, Principal Investigator, Pontificia Universidad Católica
  • Overall Contact(s)
    • José Luis Tapia, MD, 56-2-3546437, jlta@med.puc.cl

References

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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 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.

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.

Lundstrøm 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. Update in: Cochrane Database Syst Rev. 2020 Oct 15;10: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. Review. Update in: Cochrane Database Syst Rev. 2016;(6):CD001243.

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.

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