title: A multicenter, randomized, double-blind trial of a new porcine surfactant in premature infants with respiratory distress syndrome.
abstract: OBJECTIVE
  To compare the efficacy and safety of a new porcine-derived pulmonary surfactant developed by Instituto Butantan with those of animal-derived surfactants commercially available in Brazil, regarding neonatal mortality and the major complications of prematurity in preterm newborns with birth weight up to 1500g and diagnosed with respiratory distress syndrome.
  
  
  METHODS
  Neonates diagnosed with respiratory distress syndrome were randomized to receive either Butantan surfactant (Butantan group) or one of the following surfactants: Survanta® or Curosurf®. Newborns receiving Survanta® or Curosurf® comprised the control group. The main outcome measures were mortality rates at 72 hours and at 28 days of life; the typical complications of prematurity as evaluated on the 28th day of life were defined as secundary outcomes.
  
  
  RESULTS
  No differences were observed between the Butantan (n=154) and control (n=173) groups in relation to birth weight, gestational age, sex, and prenatal use of corticosteroids, or in mortality rates both at 72 hours (14.19% versus 14.12%; p=0.98) and at 28 days (39.86% versus 33.33%; p=0.24) of life. Higher 1- and 5-minute Apgar scores were observed among control group newborns. No differences were observed as regards the secondary outcomes, except for greater need for supplemental oxygen and a higher incidence of interstitial pulmonary emphysema in the Butantan group.
  
  
  CONCLUSIONS
  The mortality rates at 72 hours and 28 days of life and the incidence of major complications of prematurity were comparable to those found with the animal-derived surfactants commercially available in Brazil, showing the efficacy and safety of the new surfactant in the treatment of respiratory distress syndrome in newborns.
authors: Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.
authors: Celso Moura
authors: CM
authors: Rebello
authors: Instituto da Criança, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.
authors: Alexander Roberto
authors: AR
authors: Precioso
authors: Maternidade Pro Matre Paulista, São Paulo, SP, Brazil.
authors: Renata Suman
authors: RS
authors: Mascaretti
mesh_terms: D001688:Biological Products / Q000627:therapeutic use*; D001724:Birth Weight; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D008297:Male; D010743:Phospholipids / Q000627:therapeutic use*; D011446:Prospective Studies; D011663:Pulmonary Surfactants / Q000627:therapeutic use*; D015203:Reproducibility of Results; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000401:mortality; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001688:Biological Products; D010743:Phospholipids; D011663:Pulmonary Surfactants; C068291:poractant alfa; C072197:beractant
references: Pediatrics. 1996 Jan;97(1):48-52
references: 8545223
references: Lancet. 1980 Jan 12;1(8159):55-9
references: 6101413
references: Respir Physiol Neurobiol. 2013 Jun 1;187(1):58-63
references: 23473924
references: Clinics (Sao Paulo). 2006 Apr;61(2):153-60
references: 16680333
references: Pediatrics. 2005 Apr;115(4):1030-8
references: 15805381
references: J Pediatr. 1998 Jan;132(1):40-7
references: 9469998
references: Pediatrics. 1972 Jul;50(1):58-66
references: 4483194
references: Pediatrics. 2008 Feb;121(2):419-32
references: 18245434
references: Cochrane Database Syst Rev. 2001;(2):CD000144
references: 11405951
references: Rev Hosp Clin Fac Med Sao Paulo. 2004 Jun;59(3):104-12
references: 15286829
references: Am J Pathol. 1986 Feb;122(2):353-62
references: 3511728
references: Chem Phys Lipids. 2005 Oct;137(1-2):77-93
references: 16109391
references: Exp Lung Res. 2009 Feb;35(1):76-88
references: 19191106
references: Early Hum Dev. 2013 Jun;89 Suppl 1:S22-4
references: 23809343
references: Pediatrics. 1991 Apr;87(4):505-10
references: 2011428
references: J Pediatr. 1993 Oct;123(4):603-10
references: 8410518
references: AMA J Dis Child. 1959 May;97(5, Part 1):517-23
references: 13649082
references: Chest. 2007 May;131(5):1577-82
references: 17494810
references: Biol Neonate. 2006;89(4):323-9
references: 16770072