title: A multicenter, randomized, controlled trial comparing Surfaxin (Lucinactant) lavage with standard care for treatment of meconium aspiration syndrome.
abstract: OBJECTIVE
  Infants with meconium aspiration syndrome (MAS) have marked surfactant dysfunction. Airways and alveoli of affected neonates contain meconium, inflammatory cells, inflammatory mediators, edema fluid, protein, and other debris. The objective of this study was to compare treatment with bronchoalveolar lavage using dilute Surfaxin with standard therapy in a population of newborn infants with MAS.
  
  
  METHODS
  Inclusion criteria were 1) gestational age > or =35 weeks, 2) enrollment within 72 hours of birth, 3) diagnosis of MAS, 4) need for mechanical ventilation, and 5) an oxygenation index > or =8 and < or =25. Subjects were randomized to either lavage with Surfaxin or standard care (2:1 proportion). In lavaged infants, a volume of 8 mL/kg dilute Surfaxin (2.5 mg/mL) was instilled into each lung over approximately 20 seconds followed by suctioning after 5 ventilator breaths. The procedure was repeated twice. The third and final lavage was with a more concentrated solution (10 mg/mL) of Surfaxin.
  
  
  RESULTS
  Twenty-two infants were enrolled (15 Surfaxin and 7 control). Demographic characteristics were similar. There were trends (not significant) for Surfaxin-lavaged infants to be weaned from mechanical ventilation earlier (mean of 6.3 vs 9.9 days, respectively), as well as to have a more rapid decline in their oxygenation indexes compared with control infants, the latter difference persisting for the 96-hour-long study period. The therapy was safe and generally well tolerated by the infants.
  
  
  CONCLUSIONS
  Dilute Surfaxin lavage seems to be a safe and potentially effective therapy in the treatment of MAS. Data from this investigation support future prospective, controlled clinical trials of bronchoalveolar lavage with Surfaxin in neonates with MAS.
authors.affiliation: Discovery Laboratories, Inc, Doylestown, Pennsylvania, USA. twiswell@mail.som.sunysb.edu
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Wiswell
authors.forename: Gail R
authors.initials: GR
authors.lastname: Knight
authors.forename: Neil N
authors.initials: NN
authors.lastname: Finer
authors.forename: Steven M
authors.initials: SM
authors.lastname: Donn
authors.forename: Hemant
authors.initials: H
authors.lastname: Desai
authors.forename: William F
authors.initials: WF
authors.lastname: Walsh
authors.forename: Krishnamurthy C
authors.initials: KC
authors.lastname: Sekar
authors.forename: Graham
authors.initials: G
authors.lastname: Bernstein
authors.forename: Martin
authors.initials: M
authors.lastname: Keszler
authors.forename: Valya E
authors.initials: VE
authors.lastname: Visser
authors.forename: T Allen
authors.initials: TA
authors.lastname: Merritt
authors.forename: Frank L
authors.initials: FL
authors.lastname: Mannino
authors.forename: Lisa
authors.initials: L
authors.lastname: Mastrioianni
authors.forename: Brian
authors.initials: B
authors.lastname: Marcy
authors.forename: Susan D
authors.initials: SD
authors.lastname: Revak
authors.forename: Huei
authors.initials: H
authors.lastname: Tsai
authors.forename: Charles G
authors.initials: CG
authors.lastname: Cochrane
mesh_terms: D018893:Bronchoalveolar Lavage / Q000379:methods*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D008471:Meconium Aspiration Syndrome / Q000097:blood / Q000628:therapy*; D010100:Oxygen / Q000097:blood; D011663:Pulmonary Surfactants / Q000627:therapeutic use*; D012121:Respiration, Artificial / Q000379:methods; D013396:Suction / Q000379:methods; D016896:Treatment Outcome; D015300:Ventilator Weaning / Q000706:statistics & numerical data
chemical_list: D011663:Pulmonary Surfactants; D010100:Oxygen