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Steroids Helping Albuterol Responders Exclusively

Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchiolitis

Intervention: prednisolone or methylprednisolone (Drug); placebo (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
Steven L Shein, MD, Principal Investigator, Affiliation: University Hospital Case Medical Center

Summary

The purpose of the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol.

Clinical Details

Official title: Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

respiratory rate and respiratory distress score

length of hospitalization (actual and until meets "ready for discharge" criteria)

Secondary outcome:

need for increased respiratory support (intubation, CPAP, BiPAP)

amount of oxygen used during hospitalization

number of doses of bronchodilators used during hospitalization

total duration of symptoms

need for unanticipated medical care after discharge

tachycardia and/or hypertension during hospitalization

Eligibility

Minimum age: N/A. Maximum age: 24 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- diagnosis of bronchiolitis

- Respiratory Distress Assessment Index score of 4 or more

Exclusion Criteria:

- prior prescription of bronchodilators or inhaled corticosteroids

- 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

Locations and Contacts

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States
Additional Information

Related publications:

American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93.

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.

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.

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.

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.

Kristjánsson S, Lødrup Carlsen KC, Wennergren G, Strannegård 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.

Gadomski AM, Bhasale AL. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001266. Review. Update in: Cochrane Database Syst Rev. 2010;(12):CD001266.

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.

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. Review. Update in: Cochrane Database Syst Rev. 2008;(1):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.

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. 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.

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.

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. Review.

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.

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.

Smith M, Iqbal S, Elliott TM, Everard M, Rowe BH. Corticosteroids for hospitalised children with acute asthma. Cochrane Database Syst Rev. 2003;(2):CD002886. Review.

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.


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