A multicenter, randomized, controlled trial of lucinactant versus poractant alfa among very premature infants at high risk for respiratory distress syndrome

Pediatrics

Volumn 115, Issue 4, 2005, Pages 1030-1038

  Sinha, Sunil K ^a,k   Lacaze Masmonteil, Thierry ^b   Valls I Soler, Adolf ^c   Wiswell, Thomas E ^d   Gadzinowski, Janusz ^e,l   Hajdu, Julia ^f   Bernstein, Graham ^g   Sanchez Luna, Manuel ^h   Segal, Robert ⁱ   Schaber, Christopher J ⁱ   Massaro, Joseph ^j   D'Agostino, Ralph ^j  

^a JAMES COOK UNIVERSITY HOSPITAL   (United Kingdom)

^b HÔPITAL ANTOINE BÉCLÈRE   (France)

^c UNIVERSITY OF THE BASQUE COUNTRY UPV EHU   (Spain)

^d STONY BROOK UNIVERSITY   (United States)

^e POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^f SEMMELWEIS UNIVERSITY   (Hungary)

^g SHARP HEALTHCARE   (United States)

^h HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

ⁱ Discovery Laboratories Inc   (United States)

^j BOSTON UNIVERSITY   (United States)

^k DURHAM UNIVERSITY   (United Kingdom)

^l POLISH MOTHER S MEMORIAL HOSPITAL RESEARCH INSTITUTE   (Poland)

more..

Author keywords

Bronchopulmonary dysplasia; KL 4; Lucinactant; Poractant alfa; Respiratory distress syndrome; Surfactant protein B

Indexed keywords

LUCINACTANT; PORACTANT; BIOLOGICAL PRODUCT; FATTY ALCOHOL; LUNG SURFACTANT; PHOSPHATIDYLGLYCEROL; PHOSPHOLIPID; PROTEIN;

ARTICLE; BIRTH WEIGHT; BRAIN HEMORRHAGE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; ENCEPHALOMALACIA; FEMALE; GESTATIONAL AGE; HUMAN; INFANT; LUNG DYSPLASIA; MAJOR CLINICAL STUDY; MALE; MENSTRUAL CYCLE; MULTICENTER STUDY; NEUROIMAGING; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY DISTRESS SYNDROME; SURVIVAL RATE; ARTIFICIAL VENTILATION; COMPARATIVE STUDY; DRUG COMBINATION; INCIDENCE; INFANT MORTALITY; MORTALITY; NEONATAL RESPIRATORY DISTRESS SYNDROME; NEWBORN; VERY LOW BIRTH WEIGHT;

BIOLOGICAL PRODUCTS; BRONCHOPULMONARY DYSPLASIA; DRUG COMBINATIONS; FATTY ALCOHOLS; FEMALE; HUMANS; INCIDENCE; INFANT MORTALITY; INFANT, NEWBORN; INFANT, PREMATURE; INFANT, PREMATURE, DISEASES; INFANT, VERY LOW BIRTH WEIGHT; INTRACRANIAL HEMORRHAGES; LEUKOMALACIA, PERIVENTRICULAR; MALE; PHOSPHATIDYLGLYCEROLS; PHOSPHOLIPIDS; PROTEINS; PULMONARY SURFACTANTS; RESPIRATION, ARTIFICIAL; RESPIRATORY DISTRESS SYNDROME, NEWBORN;

EID: 23244442451     PISSN: 00314005     EISSN: 00314005     Source Type: Journal    
DOI: 10.1542/peds.2004-2231     Document Type: Article

References (37)

1. Soll RF. Prophylactic synthetic surfactant for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 1998;(2):CD001079
2. Soll RF. Prophylactic natural surfactant for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 1997;(4):CD000511
3. Suresh GK, Soll RF. Lung surfactants for neonatal respiratory distress syndrome: animal-derived or synthetic agents? Paediatr Drugs. 2002;4:485-489
4. Soll RF, Blanco F. Natural surfactant extract versus synthetic surfactant for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2001;(2):CD000144
5. Ainsworth SB, Beresford MW, Milligan DWA, et al. Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25-29 weeks' gestation: a randomised trial. Lancet. 2000;355:1387-1392
6. Curstedt T, Jornvall H, Robertson B, et al. Two hydrophobic, low-molecular mass protein fractions of pulmonary surfactant: characterization and biophysical activity. Eur J Biochem. 1987;168:255-262
7. Clark JC, Wert S, Bachurski CJ, et al. Targeted disruption of the surfactant protein B gene disrupts surfactant homeostasis, causing respiratory failure in newborn mice. Proc Natl Acad Sci USA. 1995;92:7794-7798
8. Hamvas A, Nogee LM, Mallory GB Jr, et al. Lung transplantation for treatment of infants with surfactant protein B deficiency. J Pediatr. 1997;130:231-239
9. Cole F, Hamvas A, Nogee LM. Genetic disorders of neonatal respiratory function. Pediatr Res. 2001;50:157-162
10. Nogee LM, de Mello DE, Dehner LP, Colten HR. Brief report: deficiency of pulmonary surfactant protein B in congenital alveolar proteinosis. N Engl J Med. 1993;328:406-410
11. Strayer DS, Hallman M, Merritt TA. Immunogenicity of surfactant. II. Porcine and bovine surfactants. Clin Exp Immunol. 1991;83:41-46
12. Robertson B, Kobayashi T, Ganzuka M, Grossmann G, Li WZ, Suzuki Y. Experimental neonatal respiratory failure induced by a monoclonal antibody to the hydrophobic surfactant-associated protein SP-B. Pediatr Res. 1991;30:239-243
13. Kobayashi T, Robertson B, Grossmann G, Nitta K, Curstedt T, Suzuki Y. Exogenous porcine surfactant (Curosurf) is inactivated by monoclonal antibody to the surfactant-associated hydrophobic protein SP-B. Acta Paediatr. 1992;81:665-671
14. Whitsett JA, Hull WM, Luse S. Failure to detect surfactant protein-specific antibodies in sera of premature infants treated with Survanta, a modified bovine surfactant. Pediatrics. 1997;87:505-510
15. Cochrane CG, Revak SD. Pulmonary surfactant protein B (SP-B): structure-function relationships. Science. 1991;254:566-568
16. Cochrane CG. Surfactant protein B and mimic peptides in the function of pulmonary surfactant. FEBS Lett. 1998;430:424-425
17. Revak SD, Merritt TA, Cochrane CG, et al. Efficacy of synthetic peptide-containing surfactant in the treatment of respiratory distress syndrome in preterm infant rhesus monkeys. Pediatr Res. 1996;39:715-724
18. 4-surfactant in preterm infants with respiratory distress syndrome. Am J Respir Crit Care Med. 1996;153:404-410
19. Halliday HL, Tarnow-Mordi WO, Corcoran JD, Patterson CC. Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curosurf 4 trial). Arch Dis Child. 1993;69:276-280
20. Food and Drug Administration. E9 statistical principles for clinical trials. Fed Regist. 1998;63:49590-49598
21. Collaborative European Multicenter Study Group. Surfactant replacement therapy for severe neonatal respiratory distress syndrome: an international randomized clinical trial. Pediatrics. 1988;82:683-691
22. Hudak ML, Martin DJ, Egan EA, et al. A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant extract in the prevention of neonatal respiratory distress syndrome. Pediatrics. 1997;100:39-50
23. Soll RF, Morley CJ. Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2001;(2):CD000510
24. Johansson J, Curstedt T, Robertson B. Artificial surfactants based on analogues of SP-B and SP-C. Pediatr Pathol Mol Med. 2001;20:501-518
25. Halliday HL, Tarnow-Mordi WO, Corcoran JD, Patterson CC. Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curosurf 4 trial). Arch Dis Child. 1993;69:276-280
26. Gilliard N, Richman PM, Merritt TA, Spragg RG. Effect of volume and dose on the pulmonary distribution of exogenous surfactant administered to normal rabbits or to rabbits with oleic acid lung injury. Am Rev Respir Dis. 1990;141:743-747
27. Van der Bleek J, Plotz FB, van Overbeek FM, et al. Distribution of exogenous surfactant in rabbits with severe respiratory failure: the effect of volume. Pediatr Res. 1993;34:154-158
28. Pocock SJ. The pros and cons of non-inferiority trails. Fundam Clin Pharmacol. 2003;17:483- 490.
29. Gomberg-Maitland M, Frison L, Haperin JL. Active-control clinical trials to establish equivalence or non-inferiority: methodological and statistical concepts linked to quality. Am Heart J. 2003;145:398-403
30. Tsong Y, Wang SJ, Hung HM, Cui L. Statistical issues on objective, design and analysis of non-inferiority active-controlled clinical trial. J Biopharm Stat. 2003;13:29-41
31. Wang SJ, Hung HM. Assessing treatment efficacy in non-inferiority trials. Control Clin Trials. 2003;24:147-155
32. Manalo E, Merritt TA, Kheiter A, Amirkhanian J, Cochrane C. Comparative effects of some serum components and proteolytic products of fibrinogen on surface tension-lowering abilities of beractant and a synthetic peptide containing surfactant KL4. Pediatr Res. 1996;39:947-952
33. Herting E, Rauprich P, Stichtenoth G, Walter G, Johansson J, Robertson B. Resistance of different surfactant preparations to inactivation by meconium. Pediatr Res. 2001;50:44-49
34. Nutt M, Patel N, Rairkar M, Niven RW. Comparison of the novel lung surfactant Surfaxin (lucinactant) with currently available commercial products. Pediatr Res. 2004;55:514A
35. 4 following surface area cycling and addition of fibrinogen. Lung. 1997;175:225-233
36. Wiswell TE, Knight GR, Finer NN, et al. A multicenter randomized controlled trial comparing Surfaxin (lucinactant) lavage with standard of care for treatment of meconium aspiration syndrome. Pediatrics. 2002;109:1081-1087
37. 4-surfactant) for acute respiratory distress syndrome. Am J Respir Crit Care Med. 1990;160:1188-1195