Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Responders/Placebo
Albuterol responders being given placebo
placebo
oral or IV placebo
Responders/Steroids
albuterol responders being given steroids
prednisolone or methylprednisolone
either prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days
Non-responders/placebo
non-albuterol responders being given placebo
placebo
oral or IV placebo
non-responders/steroids
non-albuterol responders being given steroids
prednisolone or methylprednisolone
either prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days
Interventions
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prednisolone or methylprednisolone
either prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days
placebo
oral or IV placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Respiratory Distress Assessment Index score of 4 or more
Exclusion Criteria
* birth at \<36 weeks gestation
* chronic cardiac disease
* chronic pulmonary disease (including asthma)
* immunodeficiency
* non-topical steroid use in the prior week
* parents that don't understand English
* baseline systolic blood pressure \>118 mmHg
* home oxygen use
* evidence of systemic fungal or varicella infection
* bronchodilator use in the prior week
* allergy to albuterol or corticosteroids
4 Weeks
24 Months
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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University Hospitals of Cleveland
Principal Investigators
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Steven L Shein, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals of Cleveland
Cleveland, Ohio, United States
Countries
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References
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American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ. Bronchiolitis-associated hospitalizations among US children, 1980-1996. JAMA. 1999 Oct 20;282(15):1440-6. doi: 10.1001/jama.282.15.1440.
Stang P, Brandenburg N, Carter B. The economic burden of respiratory syncytial virus-associated bronchiolitis hospitalizations. Arch Pediatr Adolesc Med. 2001 Jan;155(1):95-6. doi: 10.1001/archpedi.155.1.95. No abstract available.
Wang EE, Law BJ, Boucher FD, Stephens D, Robinson JL, Dobson S, Langley JM, McDonald J, MacDonald NE, Mitchell I. Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) study of admission and management variation in patients hospitalized with respiratory syncytial viral lower respiratory tract infection. J Pediatr. 1996 Sep;129(3):390-5. doi: 10.1016/s0022-3476(96)70071-9.
Schweich PJ, Hurt TL, Walkley EI, Mullen N, Archibald LF. The use of nebulized albuterol in wheezing infants. Pediatr Emerg Care. 1992 Aug;8(4):184-8. doi: 10.1097/00006565-199208000-00003.
Kristjansson S, Lodrup Carlsen KC, Wennergren G, Strannegard IL, Carlsen KH. Nebulised racemic adrenaline in the treatment of acute bronchiolitis in infants and toddlers. Arch Dis Child. 1993 Dec;69(6):650-4. doi: 10.1136/adc.69.6.650.
Gadomski AM, Bhasale AL. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001266. doi: 10.1002/14651858.CD001266.pub2.
Dobson JV, Stephens-Groff SM, McMahon SR, Stemmler MM, Brallier SL, Bay C. The use of albuterol in hospitalized infants with bronchiolitis. Pediatrics. 1998 Mar;101(3 Pt 1):361-8. doi: 10.1542/peds.101.3.361.
Patel H, Platt R, Lozano JM, Wang EE. Glucocorticoids for acute viral bronchiolitis in infants and young children. Cochrane Database Syst Rev. 2004;(3):CD004878. doi: 10.1002/14651858.CD004878.
Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL. Systemic corticosteroids in infant bronchiolitis: A meta-analysis. Pediatrics. 2000 Apr;105(4):E44. doi: 10.1542/peds.105.4.e44.
Kuzik BA, Al-Qadhi SA, Kent S, Flavin MP, Hopman W, Hotte S, Gander S. Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. J Pediatr. 2007 Sep;151(3):266-70, 270.e1. doi: 10.1016/j.jpeds.2007.04.010. Epub 2007 Jun 29.
Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003 Nov;143(5 Suppl):S127-32. doi: 10.1067/s0022-3476(03)00510-9.
Rodriguez WJ, Gruber WC, Groothuis JR, Simoes EA, Rosas AJ, Lepow M, Kramer A, Hemming V. Respiratory syncytial virus immune globulin treatment of RSV lower respiratory tract infection in previously healthy children. Pediatrics. 1997 Dec;100(6):937-42. doi: 10.1542/peds.100.6.937.
Hartling L, Wiebe N, Russell K, Patel H, Klassen TP. A meta-analysis of randomized controlled trials evaluating the efficacy of epinephrine for the treatment of acute viral bronchiolitis. Arch Pediatr Adolesc Med. 2003 Oct;157(10):957-64. doi: 10.1001/archpedi.157.10.957.
Wainwright C, Altamirano L, Cheney M, Cheney J, Barber S, Price D, Moloney S, Kimberley A, Woolfield N, Cadzow S, Fiumara F, Wilson P, Mego S, VandeVelde D, Sanders S, O'Rourke P, Francis P. A multicenter, randomized, double-blind, controlled trial of nebulized epinephrine in infants with acute bronchiolitis. N Engl J Med. 2003 Jul 3;349(1):27-35. doi: 10.1056/NEJMoa022226.
Tal A, Levy N, Bearman JE. Methylprednisolone therapy for acute asthma in infants and toddlers: a controlled clinical trial. Pediatrics. 1990 Sep;86(3):350-6.
Connett GJ, Warde C, Wooler E, Lenney W. Prednisolone and salbutamol in the hospital treatment of acute asthma. Arch Dis Child. 1994 Mar;70(3):170-3. doi: 10.1136/adc.70.3.170.
Smith M, Iqbal S, Elliott TM, Everard M, Rowe BH. Corticosteroids for hospitalised children with acute asthma. Cochrane Database Syst Rev. 2003;2003(2):CD002886. doi: 10.1002/14651858.CD002886.
Gorelick MH, Shaw KN, Murphy KO. Validity and reliability of clinical signs in the diagnosis of dehydration in children. Pediatrics. 1997 May;99(5):E6. doi: 10.1542/peds.99.5.e6.
Other Identifiers
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UHC 07-08-36
Identifier Type: -
Identifier Source: org_study_id