Early intratracheal instillation of budesonide using surfactant as a vehicle to prevent chronic lung disease in preterm infants: A pilot study

Pediatrics

Volumn 121, Issue 5, 2008, Pages

  Yeh, Tsu F ^a,f,g,h   Lin, Hong C ^a   Chang, Chien H ^c   Wu, Tien S ^c,d   Su, Bai H ^a   Li, Tsai C ^b   Pyati, Suma ^f   Tsai, Chang H ^e  

^a School of Chinese Medicine   (Taiwan)

^b CHINA MEDICAL UNIVERSITY   (Taiwan)

^c NATIONAL CHENG KUNG UNIVERSITY   (Taiwan)

^d NATIONAL RESEARCH INSTITUTE OF CHINESE MEDICINE   (Taiwan)

^e ASIA UNIVERSITY   (Taiwan)

^f Jr Hospital of Cook County   (United States)

^g CHINA MEDICAL UNIVERSITY   (Taiwan)

^h John H Stroger Hospital of Cook County   (United States)

Author keywords

Budesonide; Chronic lung disease; Survanta

Indexed keywords

BERACTANT; BUDESONIDE; DEXAMETHASONE; DOPAMINE; INDOMETACIN; SURFACTANT; 16 HYDROXYPREDNISOLONE; 16-HYDROXYPREDNISOLONE; BIOLOGICAL PRODUCT; DRUG DERIVATIVE; DRUG VEHICLE; GLUCOCORTICOID; LUNG SURFACTANT; PREDNISOLONE;

AIRWAY PRESSURE; AREA UNDER THE CURVE; ARTICLE; ARTIFICIAL VENTILATION; CARBON DIOXIDE TENSION; CHILD; CHRONIC LUNG DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; EXTUBATION; FEMALE; HUMAN; INFANT; LOW BIRTH WEIGHT; MALE; MORBIDITY; MORTALITY; PATENT DUCTUS ARTERIOSUS; PILOT STUDY; PREMATURITY; PRIORITY JOURNAL; PROSPECTIVE STUDY; PUERPERIUM; RADIODIAGNOSIS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY DISTRESS; RESPIRATORY DISTRESS SYNDROME; RESPIRATORY FAILURE; UNSPECIFIED SIDE EFFECT; CHRONIC DISEASE; DOUBLE BLIND PROCEDURE; DRUG INSTILLATION; LUNG DISEASE; NEONATAL RESPIRATORY DISTRESS SYNDROME; NEWBORN; PATHOPHYSIOLOGY; SURVIVAL RATE; VEHICLES; VERY LOW BIRTH WEIGHT;

BIOLOGICAL PRODUCTS; BUDESONIDE; CHRONIC DISEASE; DOUBLE-BLIND METHOD; FEMALE; GLUCOCORTICOIDS; HUMANS; INFANT, NEWBORN; INFANT, VERY LOW BIRTH WEIGHT; INSTILLATION, DRUG; LUNG DISEASES; MALE; PREDNISOLONE; PULMONARY SURFACTANTS; RESPIRATION, ARTIFICIAL; RESPIRATORY DISTRESS SYNDROME, NEWBORN; SURVIVAL RATE; VEHICLES;

EID: 44449106249     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2007-1973     Document Type: Article

References (43)

1. Yeh TF, Lin YJ, Hsieh WS, et al. Early postnatal dexamethasone therapy for the prevention of chronic lung disease in preterm infants with respiratory distress syndrome: a multicenter clinical trial. Pediatrics. 1997;100(4). Available at: www.pediatrics.org/cgi/content/full/100/4/e3
2. Collaborative Dexamethasone Trial Group. Dexamethasone therapy in neonatal chronic lung disease: an international placebo-controlled trial. Pediatrics. 1991;88(3):421-427
3. Cummings JJ, D'Eugenio DB, Gross SJ. A controlled trial of dexamethasone in preterm infants at high risk for bronchopulmonary dysplasia. N Engl J Med. 1989;320(23):1505-1510
4. Vermont Oxford Network Steroid Study Group. Early postnatal dexamethasone therapy for the prevention of chronic lung disease. Pediatrics. 2001;108(3):741-748
5. Yeh TF, Lin YJ, Huang CC, et al. Early dexamethasone therapy in preterm infants: a follow-up study. Pediatrics. 1998;101(5). Available at: www.pediatrics.org/cgi/content/full/101/5/e7
6. Halliday HL, Ehrenkranz RA. Early postnatal (<96 hours) corticosteroids for preventing chronic lung disease in preterm infants. Cochrane Database Syst Rev. 2000;(2):CD001146
7. Yeh TF, Lin YJ, Lin HC, et al. Outcome at school age after postnatal dexamethasone therapy for lung disease of prematurity. N Engl J Med. 2004;350(13):1304-1313
8. Yeh TF, Torre JA, Rastogi A, Anyebuno MA, Pildes RS. Early postnatal dexamethasone therapy in premature infants with severe respiratory distress syndrome: a double-blind, controlled study. J Pediatr. 1990;117(2 pt 1):273-282
9. Mammel MC, Green TP, Johnson DE, Thompson TR. Controlled trial of dexamethasone therapy in infants with bron-chopulmonary dysplasia. Lancet. 1983;1(8338):1356-1358
10. Avery GB, Fletcher AB, Kaplan M, Brudno DS. Controlled trial of dexamethasone in respirator-dependent infants with bron-chopulmonary dysplasia. Pediatrics. 1985;75(1):106-111
11. Shah SS, Ohlsson A, Halliday H, Shah VS. Inhaled versus systemic corticosteroids for preventing chronic lung disease in ventilated very low birth weight neonates. Cochrane Database Syst Rev. 2003;(1):CD002058
12. Fok TF, Monkman S. Dolovich M, et al. Efficiency of aerosol medication delivery from a metered dose inhaler versus jet nebulizer in infants with bronchopulmonary dysplasia. Ped Pulm. 1996;21(5):301-309
13. Arnon S. Grigg J, Nikander K, Silverman M. Delivery of micronized budesonide suspension by metered dose inhaler and jet nebulizer into a neonatal ventilator circuit. Pediatr Pulmonol. 1992;13(3):172-175
14. Kovacs L, Davis GM, Faucher D, Papageorgiou A. Efficacy of sequential early systemic and inhaled corticosteroid therapy in the prevention of chronic lung disease of prematurity. Acta Paediatr. 1998;87(7):792-798
15. Grigg J, Arnon S, Jones T, Clarke A, Silverman M. Delivery of therapeutic aerosols to intubated babies. Arch Dis Child. 1992; 67(1):25-30
16. O'Callaghan C, Hardy J, Stammers J, Stephenson TJ, Hull D. Evaluation of techniques for delivery of steroids to lungs of neonates using a rabbit model. Arch Dis Child. 1992;67(1): 20-24
17. Cole CH, Colton T, Shah BL, et al. Early inhaled glucocorticoid therapy to prevent bronchopulmonary dysplasia. N Engl J Med. 1999;340(13):1005- 1010
18. Lin YJ, Lin HC, Lin CH, Su BH, Yeh TF. Early endotracheal instillation of budesonide (B) for prevention of CLD in preterm infant with RDS-a double blind clinical trial. Ped Res. 2001; 49(4):278A
19. Fujiwara T, Chida S, Watabe Y, Maeta H, Morita T, Abe T. Artificial surfactant therapy in hyaline membrane disease. Lancet. 1980;1(8159):55-59
20. Ferrara TB, Hoekstra RE, Johnson P, Vernier RL. Localization of surfactant in neonatal lung after exogenous administration. J Pediatr. 1987;111(3):463-466
21. Adamson AW. Introduction Marongoni convection. In: Adam-son AW. Physical Chemistry of Surfaces. New York, NY: John Wiley and Sons; 1982:110
22. Fajardo C, Levin D, Garcia M, Adrams D, Adamson I. Surfactant versus saline as a vehicle for corticosteroid delivery to the lungs of ventilated rabbits. Pediatr Res. 1998;43(4 pt 1):542-547
23. Kharasch VS, Sweeney TD, Fredberg J, et al. Pulmonary surfactant as a vehicle for intratracheal delivery of technetium sulfur colloid and pentamidine in hamster lungs. Am Rev Respir Dis. 1991;144(4):909-913
24. Brattsand R, Thalen A, Roempke K, Kallstron L, Gruvstad E. Development of new glucocorticosteroids with a very high ratio between topical and systemic activities. Eur J Respir Dis. 1988;2(Suppl):122:62073
25. Hvizdos KM, Jarvis B. Budesonide inhalation suspension: a review of its use in infants, children and adults with inflammatory respiratory disorders. Drugs. 2000;60(5):1141-1178
26. Johansson SA, Anderson KE, Brattsand R, Gruvstad E, Hedner P. Topical and systemic glucocorticoid potencies of budesonide and beclomethasone dipropionate in man. Eur J Chin Pharmacol. 1982;22(6):523-529
27. Ryrfeldt A, Edsbacker S, Pauwels R. Kinetics of the epimeric glucocorticoid budesonide. Clin Pharmacol Ther. 1984;35(4): 525-530
28. Fleiss JL. Statistical Methods for Rates and Proportions. New York, NY: John Wiley & Sons; 1973:23-35
29. Palmer, D, Schurch, S, Belik J. Effect of budesonide and salbutamol on surfactant properties. J Appl Physiol. 2000;89(3): 884-890
30. Chang DH, Chang CH, Lin YJ, Yeh TF. Influence of budesonide (B) on the dynamic surface tension behavior of surfactant (survanta) (s) at pulsating air-liquid interface. Ped Res. 2002; 51(4):346A
31. BisgaardH, MunchE, NikanderK. Equrpotency of budesonide administration from a MDI and from a nebulized suspension. Eur Reopir J. 1989;2(suppl 8):769S
32. Schouten-Van Meeteren NYN, Rietveld A, Moolenaar AJ, Van Bel F. Influence of perinatal condition on C-reactive protein production. J Pediatr. 1992;120(4pt 1):621-626
33. Wang Y, Tan Y, Moellmann H, Hochhaus G. Simultaneous quantification of budesonide and its two metabolites, 6 B-hydroxyl budesonide and 16 α-hydroxyprednisolone, in human plasma by liquid chromatography negative electrospray ionization tandem mass spectrometry. Biomed Chromatogr. 2003;17:158-164
34. Nimmo AJ, Carstairs JR, Patole SK, Whitehall J, Davidson K, Vink R. Intratracheal administration of glucocorticoids using surfactant as a vehicle. Clin Exper Pharmcol Physiology. 2002; 29(8):661-665
35. Chen CM, Fang CL, Chang CH. Surfactant and corticosteroid effects on lung function in a rat model of acute lung injury. Crit Care Med. 2001;29(11):2169-2175
36. Patole SK, Mohan MS, Jog SM, Muller R, Whitehall JS. Prophylactic intratracheal budesonide in preterm neonates at risk for chronic lung disease (CLD)-a pilot study. Presented at the Annual Conference of the Perinatal Society of Australia and New Zealand; March 2-3, 2001; Canberra, Australia; No. 1590
37. Wu JM, Yeh TF, Wang JY, et al. The role of pulmonary inflammation in the development of pulmonary hypertension in newborn with meconium aspiration syndrome (MAS). Ped Pul. 1999;18(suppl):205-208
38. Vogt BA, Avner ED. The kidney and urinary tract. In: Fanaroff AA, Martin R, eds. Neonatal-Perinatal Medicine. 7th ed. Vol 2. St Louis, MO: Mosby; 2002:1526-1527
39. Van Den Bosch, JMM, Westermann CJJ, Aumann J, Edbacker S, Tonnesson M, Selroos O. Relationship between lung tissue and blood plasma concentrations of inhaled budesonide. Biopharm Drug Dispos. 1993;14(5):455-459
40. Plam S, Wiedmann TS. Note: dissolution of aerosol particles of buesonide in Survanta TM, a model lung surfactant. J Pharmaeutical Sci. 2001;90(1):98-104
41. Wiedmann TS, Bhatia R, Wattenberg LW. Drug solubilization in lung surfactant. J Control Release. 2000;65(1-2):43-47
42. Miller-Larsson A, Mattsson H, Hjertberg E, Dahlback M, Tunke A, Brattsand R. Reversible fatty acid conjugation of budes-onide: novel mechanism for prolonged retention of topically applied steroid in airway tissue. Drug Metab Dispos. 1998;26(7): 623-630
43. Borchard G, Cassara ML, Roemele, PEH, Florea BI, Junginer HE. Transport and local metabolism of budesonide and fluti-casone propionate in a human bronchial epithelial cell line (calu-3). J Pharm Sci. 2002;91(6):1561-1566