Randomized controlled trial of three different doses of aerosol beclomethasone versus systemic dexamethasone to promote extubation in ventilated premature infants

Pediatric Pulmonology

Volumn 35, Issue 5, 2003, Pages 375-383

  Rozycki, Henry J ^a   Byron, Peter R ^a   Elliott, Greg R ^a   Carroll, Timothy ^a   Gutcher, Gary R ^a  

^a VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Chronic lung disease; Corticosteroids; Premature infants

Indexed keywords

BECLOMETASONE DIPROPIONATE; DEXAMETHASONE; PLACEBO;

ARTICLE; ARTIFICIAL VENTILATION; BIRTH WEIGHT; BLOOD PRESSURE; CHRONIC LUNG DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; EXTUBATION; FEMALE; GESTATIONAL AGE; GLUCOSE BLOOD LEVEL; HIGH RISK POPULATION; HUMAN; INFANT; LEUKOCYTE COUNT; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; METERED DOSE INHALER; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADMINISTRATION, INHALATION; ANTI-INFLAMMATORY AGENTS; BECLOMETHASONE; CHRONIC DISEASE; DEVICE REMOVAL; DEXAMETHASONE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INFANT, NEWBORN; INFANT, PREMATURE; INTUBATION, INTRATRACHEAL; LUNG DISEASES; MALE; OUTCOME ASSESSMENT (HEALTH CARE); RESPIRATION, ARTIFICIAL; RESPIRATORY FUNCTION TESTS; VENTILATOR WEANING;

EID: 0037730280     PISSN: 87556863     EISSN: None     Source Type: Journal    
DOI: 10.1002/ppul.10269     Document Type: Article

References (43)

1. Mammel MC, Green TP, Johnson DE, Thompson TR. Controlled trial of dexamethasone therapy in infants with bronchopulmonary dysplasia. Lancet 1983;1:1356-1358.
2. Avery GB, Fletcher AB, Kaplan M, Brudno DS. Controlled trial of dexamethasone in respirator-dependent infants with bronchopulmonary dysplasia. Pediatrics 1985;75:106-111.
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;320:1505-1510.
4. Groneck P, Reuss D, Gotze-Speer B, Speer CP. Effects of dexamethasone on chemotactic activity and inflammatory mediators in tracheobronchial aspirates of preterm infants at risk for chronic lung disease. J Pediatr 1993;122:938-944.
5. Yoder MC, Chua R, Tepper R. Effect of dexamethasone on pulmonary inflammation and pulmonary function of ventilator-dependent infants with bronchopulmonary dysplasia. Am Rev Respir Dis 1991;143:1044-1048.
6. O'Neil EA, Chwals WJ, O'Shea MD, Turner CS. Dexamethasone treatment during ventilator dependency: possible life threatening gastrointestinal complications. Arch Dis Child 1992;67: 10-11.
7. Smets K, Vanhaesebrouck P. Dexamethasone associated systemic hypertension in low birth weight babies with chronic lung disease. Eur J Pediatr 1996;155:573-575.
8. O'Shea TM, Kothadia JM, Klinepeter KL, Goldstein DJ, Jackson BG, Weaver RG III, Dillard RG. Randomized placebo-controlled trial of a 42-day tapering course of dexamethasone to reduce the duration of ventilator dependency in very low birth weight infants: outcome of study participants at 1-year adjusted age. Pediatrics 1999;104:15-21.
9. Merz U, Peschgens T, Kusenbach G, Hornchen H. Early versus late dexamethasone treatment in preterm infants at risk for chronic lung disease: a randomized pilot study. Eur J Pediatr 1999; 158:318-322.
10. Papile LA, Tyson JE, Stoll BJ, Wright LL, Donovan EF, Bauer CR, Krause-Steinrauf H, Verter J, Korones SB, Lemons JA, Fanaroff AA, Stevenson DK. A multicenter trial of two dexamethasone regimens in ventilator-dependent premature infants. N Engl J Med 1998;338:1112-1118.
11. Garland JS, Alex CP, Pauly TH, Whitehead VL, Brand J, Winston JF, Samuels DP, McAuliffe TL. A three-day course of dexamethasone therapy to prevent chronic lung disease in ventilated neonates: a randomized trial. Pediatrics 1999;104:91-99.
12. Brozanski BS, Jones JG, Gilmour CH, Balsan MJ, Vazquez RL, Israel BA, Newman B, Mimouni FB, Guthrie RD. Effect of pulse dexamethasone therapy on the incidence and severity of chronic lung disease in the very low birth weight infant. J Pediatr 1995; 126:769-776.
13. Kothadia JM, O'Shea TM, Roberts D, Auringer ST, Weaver RG III, Dillard RG. Randomized placebo-controlled trial of a 42-day tapering course of dexamethasone to reduce the duration of ventilator dependency in very low birth weight infants. Pediatrics 1999;104:22-27.
14. Borish L, Mascali JJ, Dishuck J, Beam WR, Martin RJ, Rosenwasser LJ. Detection of alveolar macrophage-derived IL-1 beta in asthma. Inhibition with corticosteroids. J Immunol 1992; 149:3078-3082.
15. Robinson D, Hamid Q, Ying S, Bentley A, Assoufi B, Durham S, Kay AB. Prednisolone treatment in asthma is associated with modulation of bronchoalveolar lavage cell interleukin-4, interleukin-5, and interferon-gamma cytokine gene expression. Am Rev Respir Dis 1993;148:401-406.
16. British Thoracic and Tuberculosis Association. Inhaled corticosteroids compared with oral prednisone in patients starting longterm corticosteroid therapy for asthma. A controlled trial. Lancet 1975;2:469-473.
17. Harkavy KL, Scanlon JW, Chowdhry PK, Grylack LJ. Dexamethasone therapy for chronic lung disease in ventilator- and oxygen-dependent infants: a controlled trial. J Pediatr 1989;115: 979-983.
18. Kazzi NJ, Brans YW, Poland RL. Dexamethasone effects on the hospital course of infants with bronchopulmonary dysplasia who are dependent on artificial ventilation. Pediatrics 1990;86:722- 727.
19. Kari MA, Heinonen K, Ikonen RS, Koivisto M, Raivio KO. Dexamethasone treatment in preterm infants at risk for bronchopulmonary dysplasia. Arch Dis Child 1993;68:566-569.
20. Durand M, Sardesai S, McEvoy C. Effects of early dexamethasone therapy on pulmonary mechanics and chronic lung disease in very low birth weight infants: a randomized controlled trial. Pediatrics 1995;95:584-590.
21. Rozycki HJ, Narla L. Early versus late identification of infants at high risk of developing moderate to severe bronchopulmonary dysplasia. Pediatr Pulmonol 1996;21:345-352.
22. Physician's desk reference, 53rd ed. Montvale, NJ: Medical Economics Co.; 1999. p 2892-2893.
23. Rozycki HJ, Byron PR, Dailey K, Gutcher GR. Evaluation of a system for the delivery of inhaled beclomethasone dipropionate to intubated neonates. Dev Pharmacol Ther 1991;16:65-70.
24. Cole CH, Colton T, Shah BL, Abbasi S, MacKinnon BL, Demissie S, Frantz ID. Early inhaled glucocorticoid therapy to prevent bronchopulmonary dysplasia. N Engl J Med 1999;340: 1005-1010.
25. Martin LE, Tanner RJN, Harrison C. Metabolism of beclomethasone dipropionate and related steroids in man. Postgrad Med J [Suppl] 1975;51:20-25.
26. Weibel ER. Functional morphology of the growing lung. Respiration [Suppl] 1970;27:27-35.
27. Groneck P, Gotze-Speer B, Oppermann M, Eiffert H, Speer CP. Association of pulmonary inflammation and increased microvascular permeability during the development of bronchopulmonary dysplasia: a sequential analysis of inflammatory mediators in respiratory fluids of high-risk preterm neonates. Pediatrics 1994;93: 712-718.
28. Ozdemir A, Brown MA, Morgan WJ. Markers and mediators of inflammation in neonatal lung disease. Pediatr Pulmonol 1997; 23:292-306.
29. Watterberg KL, Scott SM. Evidence of early adrenal insufficiency in babies who develop bronchopulmonary dysplasia. Pediatrics 1995;95:120-125.
30. Liu EA, Heldt GP. A trial of the safety of inhaled beclomethasone in ventilator-treated neonates. J Pediatr 1996;129:154-156.
31. Arnon S, Grigg J, Silverman M. Effectiveness of budesonide aerosol in ventilator-dependent preterm babies: a preliminary report. Pediatr Pulmonol 1996;21:231-235.
32. Merz U, Kusenbach G, Hausler M, Peschgens T, Hornchen H. Inhaled budesonide in ventilator-dependent preterm infants: a randomized, double-blind pilot study. Biol Neonate 1999;75: 46-53.
33. Williams DM. Clinical considerations in the use of inhaled steroids for asthma. Pharmacotherapy 2001;21:38-48.
34. Giep T, Raibble P, Zuerlein T, Schwartz ID. Trial of beclomethasone dipropionate by metered-dose inhaler in ventilator-dependent neonates less than 1500 grams. Am J Perinatol 1996; 13:5-9.
35. Fok TF, Lam K, Dolovich M, Ng PC, Wong W, Cheung KL, So KW. Randomised controlled study of early use of inhaled corticosteroid in preterm infants with respiratory distress syndrome. Arch Dis Child 1999;80:203-208.
36. Dimitriou G, Greenough A, Giffin FJ, Kavadia V. Inhaled versus systemic steroids in chronic oxygen dependency of preterm infants. Eur J Pediatr 1997;156:51-55.
37. 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;87:792-798.
38. Shah V, Ohlsson A, Halliday HL, Dunn MS. Early administration of inhaled corticosteroids for preventing chronic lung disease in ventilated very low birth weight preterm neonates. Cochrane Library 2000; issue 4 (see also www.nichd.nih.gov/cochrane/shah2/shah.htm).
39. Fok TF, Monkman S, Dolovich M, Gray S, Coates G, Paes B, Rashid F, Newhouse M, Kirpalani H. Efficiency of aerosol medication delivery from a metered dose inhaler versus jet nebulizer in infants with bronchopulmonary dysplasia. Pediatr Pulmonol 1996;21:301-309.
40. Groneck P, Goetze-Speer B, Speer CP. Effects of inhaled beclomethasone compared to systemic dexamethasone on lung inflammation in preterm infants at risk of chronic lung disease. Pediatr Pulmonol 1999;27:383-387.
41. Gupta GK, Cole CH, Abbasi S, Demissie S, Njinimbam C, Nielsen HC, Colton T, Frantz ID. Effects of early inhaled beclomethasone therapy on tracheal aspirate inflammatory mediators IL-8 and IL-1ra in ventilated preterm infants at risk for bronchopulmonary dysplasia. Pediatr Pulmonol 2000;30:275-281.
42. Ramsay PL, O'Brian Smith E, Hegemier S, Welty SE. Early clinical markers for the development of bronchopulmonary dysplasia: soluble E-selectin and ICAM-1. Pediatrics 1998;102: 927-932.
43. Stefano JL, Spear ML, Pearlman SA, Fawcett P, Proujansky R. Soluble interleukin-2 receptor levels in infants with bronchopulmonary dysplasia. Pediatr Pulmonol 1992;14:58-62.