Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25-29 weeks' gestation: A randomised trial

Lancet

Volumn 355, Issue 9213, 2000, Pages 1387-1392

  Ainsworth, S B ^a   Beresford, M W ^b   Milligan, D W A ^a   Shaw, N J ^b   Matthews, J N S ^c   Fenton, A C ^a   Ward Platt, M P ^a  

^a ROYAL VICTORIA INFIRMARY   (United Kingdom)

^b LIVERPOOL WOMEN S HOSPITAL   (United Kingdom)

^c NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTIFICIAL LUNG SURFACTANT; PORACTANT; UNCLASSIFIED DRUG;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; GESTATIONAL AGE; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; NEONATAL RESPIRATORY DISTRESS SYNDROME; NEWBORN; NEWBORN MORTALITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

EID: 0034701551     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(00)02136-X     Document Type: Article

References (34)

1. Soll R.F. Prophylactic administration of natural surfactant extract (Cochrane Review). In: The Cochrane Library, Issue 2. 1999;Update Software, Oxford.
2. Soll R.F. Prophylactic synthetic surfactant in preterm infants (Cochrane Review). In: The Cochrane Library, Issue 2. 1999;Update Software, Oxford.
3. Jobe A.H., Mitchell B.R., Gunkel J.H. Beneficial effects of the combined use of prenatal corticosteroids and postnatal surfactant on preterm infants. Am J Obstet Gynecol. 168:1993;508-513.
4. Halliday H.L. Natural vs synthetic surfactants in neonatal respiratory distress syndrome. Drugs. 51:1996;226-237.
5. Soll R.F. Natural surfactant extract versus synthetic surfactant for neonatal respiratory distress syndrome (Cochrane Review). In: The Cochrane Library, Issue 2. 1999;Update Software, Oxford.
6. Corcoran J.D., Berggren P., Sun B., Halliday H.L., Robertson B., Curstedt T. Comparison of surface properties and physiological effects of a synthetic and natural surfactant in preterm rabbits. Arch Dis Child Fetal Neonatal Ed. 71:1994;F165-169.
7. Takahashi A., Nemoto T., Fujiwara T. Biophysical properties of protein-free, totally synthetic surfactants, ALEC and Exosurf, in comparison with surfactant TA. Acta Pediatr Jpn. 36:1994;613-618.
8. Morley C., Robertson B., Lachman B., Bangham A., Grossman G., Miller N. Artificial surfactant and natural surfactant. comparative study of the effects on premature rabbit lungs Arch Dis Child. 55:1980;758-765.
9. Morley C.J., Bangham A.D., Miller N., Davis A.J. Dry artificial lung surfactant and its effect on very premature babies. Lancet. i:1981;65-68.
10. Milner A.D., Vyas H., Hopkin I.E. Effects of artificial surfactant on lung function and blood gases in idiopathic respiratory distress syndrome. Arch Dis Child. 58:1983;458-460.
11. Wilkinson A., Jenkins P.A., Jeffrey J.A. Two controlled trials of artificial surfactant: early effects and later outcome in babies with surfactant deficiency. Lancet. ii:1985;287-291.
12. Ten centre trial of artificial surfactant (artificial lung expanding compound) in very premature babies. BMJ. 294:1987;991-996.
13. Morley C.J., Greenough A., Miller N.G.et al. Randomized trial of artificial surfactant (ALEC) given at birth to babies from 23 to 34 weeks gestation. Early Hum Dev. 17:1988;41-54.
14. Speer C.P., Gefeller O., Groneck P.et al. Randomised clinical trial of two treatment regimens of natural surfactant preparations in neonatal respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 72:1995;F8-13.
15. Measuring neonatal nursing workload. Arch Dis Child. 68:1993;539-543.
16. Papile L.A., Burstein J., Burstein R., Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage. a study of infants birth weight less than 1500g J Pediatr. 92:1978;529-534.
17. Levene M.I. Measurement of the growth of the lateral ventricles in preterm infants with real-time ultrasound. Arch Dis Child. 56:1981;900-904.
18. Bell M.J., Ternberg J.L., Feigin R.D.et al. Neonatal enterocolitis. therapeutic decisions based on clinical staging Ann Surg. 187:1978;1-7.
19. Retinopathy of prematurity: guidelines for screening and treatment. London: Royal College of Ophthalmologists and British Association of Perinatal Medicine, 1995. Early Hum Dev. 46:1996;239-258.
20. Thomas D.G. Exact confidence limits for the odds ratio in a two by two table. algorithm AS 36 Appl Stat. 20:1971;105-110.
21. The CRIB (critical risk index for babies) score: a tool for assessing initial neonatal risk and comparing performance of neonatal intensive care units. Lancet. 342:1993;193-198.
22. Richardson D.K., Gray J.E., McCormick M.C., Workman K., Goldman D.A. Score for neonatal acute physiology. a physiologic severity index for neonatal intensive care Pediatrics. 91:1993;617-623.
23. Maier R.F., Rey M., Metze B.C., Obladen M. Comparison of mortality risk: a score for very low birth weight infants. Arch Dis Child Fetal Neonatal Ed. 76:1997;F146-151.
24. Stenson B.J., Glover R.M., Parry G.J., Wilkie R.A., Laing I.A., Tarnow-Mordi W.O. Static respiratory compliance in the newborn. III: early changes after exogenous surfactant treatment. Arch Dis Child Fetal Neonatal Ed. 70:1994;F19-24.
25. Creuwels L.A., van Golde L.M., Haagsman H.P. The pulmonary surfactant system. biochemical and clinical aspects Lung. 175:1997;1-39.
26. Rider E.D., Ikegami M., Whitsett J.A., Hull W., Absolom D., Jobe A.H. Treatment responses to surfactants containing natural surfactant proteins in preterm rabbits. Am Rev Respir Dis. 147:1993;669-676.
27. Nogee L.M., deMello D.E., Dehner L.P., Colten H.R. Deficiency of pulmonary surfactant protein B in congenital alveolar proteinosis. N Engl J Med. 328:1993;406-410.
28. Horbar J.D., Wright L.L., Soll R.F.et al. A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. J Pediatr. 123:1994;757-766.
29. A multicenter, randomized trial comparing synthetic surfactant to modified bovine surfactant in the treatment of neonatal repiratory distress syndrome. Pediatrics. 97:1996;1-6.
30. Seidner S.R., Ikegami M., Yamada T., Rider E.D., Castro R., Jobe A.H. Decreased surfactant dose-response after delayed administration to preterm rabbits. Am J Respir Crit Care Med. 152:1995;113-120.
31. Björklund L.J., Ingimarsson J., Curstedt T.et al. Manual ventilation with a few large breaths at birth compromises the therapeutic effect of subsequent surfactant replacement in immature lambs. Pediatr Res. 42:1997;348-355.
32. Ikegami M., Jobe A.H., Tabor B.L., Rider E.D., Lewis J.F. Lung albumin recovery in surfactant-treated preterm ventilated lambs. Am Rev Respir Dis. 145:1992;1005-1008.
33. Soll R.F., Morley C. Prophyalctic versus selective use of surfactant for preventing morbidity and mortality in preterm infants. (Cochrane review) In: The Cochrane Library, Issue 2. 1999;Update Software, Oxford.
34. Hudak M.L., Martin D.J., Egan E.A.et al. A multicenter randomized masked comparison trial of synthetic surfactant versus calf lung surfactant extract for the prevention of neonatal respiratory distress syndrome. Pediatrics. 100:1997;39-50.