NCT03436225

Brief Summary

The aim of the present study is to evaluate the efficacy of steroid therapy and hospital stay in patients with acute bronchiolitis at assiut university children hospital.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

Same day

First QC Date

February 12, 2018

Last Update Submit

January 8, 2019

Conditions

Bronchiolitis; Respiratory Syncytial Virus

Keywords

steroid therapy.

Outcome Measures

Primary Outcomes (1)

  • Resolution of respiratory distress.

    A total clinical score ≤ 3 and oxygen saturation ≥ 95 % at room air together with respiratory score of 0 or 1, a wheezing score of 0 or 1, and a retraction muscle score of 0 or 1

    <7 days

Secondary Outcomes (3)

  • Reduction of mean duration of symptoms.

    <7 days

  • Reduction of duration of oxygen therapy.

    <7 days

  • Reduction of average Length of hospital stay.

    <7 days

Study Arms (4)

Group one

OTHER

Group one will receive dexamethasone orally (0.15mg /kg / dose) twice daily for 3 to 5 days.

Drug: Dexamethasone orally.

Group two

OTHER

Group two will receive dexamethasone parenteral (0.15mg /kg /dose) twice daily for 3 to 5 days.

Drug: Dexamethasone parenteral.

Group three

OTHER

Group three will receive inhaled nebulized budesonide (1 mg/2ml) twice daily for 3 to 5 days.

Drug: Inhaled nebulized Budesonide.

Group four

OTHER

Group four will receive symptomatic treatment in form of inhaled nebulized salbutamol(0.15mg/kg/ dose) daily every 6-8 hours.

Drug: Inhaled nebulized salbutamol.

Interventions

Dexamethasone orally.DRUG

Administered orally (0.15mg /kg / dose) twice daily for 3 to 5 days.

Also known as: Apidone syrup., Phenadone syrup.
Group one
Dexamethasone parenteral.DRUG

Administered parenteral (0.15mg /kg / dose) twice daily for 3 to 5 days.

Also known as: Fortecortin 8 mg /2 ml ampoule i.v /i.m injection .
Group two
Inhaled nebulized Budesonide.DRUG

Administered for inhalation (1 mg/ 2ml) twice daily for 3 to 5 days.

Also known as: Pulmicorte respules1 mg /2 ml.
Group three
Inhaled nebulized salbutamol.DRUG

Administered for inhalation (0.15mg /kg / dose) daily every 6-8hrs

Also known as: Farcoline respirator 0,5% solution.
Group four

Eligibility Criteria

Age3 Months - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants and young children aged from 3 months to 2 years with acute bronchiolitis.
  • Infants aged \<12 months with respiratory rate over 60 breaths/min, childrens aged \>12months with respiratory rate over 50 breaths/min.
  • Patients with an O2- saturation, breathing room air, under 95%.
  • Patients with apathy and/or refusal to eat.
  • Patients with normal white blood cell count for age.
  • Full term babies without chronic disease.

You may not qualify if:

  • Infants aged \< 3 months, children aged \>2 years
  • known or suspected asthma (by observing the good response to first dose of salbutamol nebulization especially among those with personal history of atopy).
  • Proven or suspected acute bacterial infection.
  • Presence of symptoms more than 7 days.
  • Previous treatment with corticosteroid by any route within 2 weeks.
  • Having a contra- indication to corticosteroid.
  • Severe cases requiring initial admission to intensive care unit with endotracheal intubation (in order to reduce confounding factors such as nosocomial infection or complication due to mechanical ventilation).
  • A previous history of intubation.
  • Premature babies (due to possible respiratory problems associated with prematurity).
  • Children with chronic cardiopulmonary diseases (Bronchopulmonary- dysplasia , Congenital Heart Disease and Cystic fibrosis)
  • Children with immunodeficiencies .
  • Children with neuromuscular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (25)

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    BACKGROUND

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    BACKGROUND

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    PMID: 17015575RESULT

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    PMID: 21817948RESULT

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    PMID: 20100768RESULT

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    PMID: 20113991RESULT

  • Carroll KN, Gebretsadik T, Griffin MR, Wu P, Dupont WD, Mitchel EF, Enriquez R, Hartert TV. Increasing burden and risk factors for bronchiolitis-related medical visits in infants enrolled in a state health care insurance plan. Pediatrics. 2008 Jul;122(1):58-64. doi: 10.1542/peds.2007-2087.

    PMID: 18595987RESULT

  • Murray J, Bottle A, Sharland M, Modi N, Aylin P, Majeed A, Saxena S; Medicines for Neonates Investigator Group. Risk factors for hospital admission with RSV bronchiolitis in England: a population-based birth cohort study. PLoS One. 2014 Feb 26;9(2):e89186. doi: 10.1371/journal.pone.0089186. eCollection 2014.

    PMID: 24586581RESULT

  • Bordley WC, Viswanathan M, King VJ, Sutton SF, Jackman AM, Sterling L, Lohr KN. Diagnosis and testing in bronchiolitis: a systematic review. Arch Pediatr Adolesc Med. 2004 Feb;158(2):119-26. doi: 10.1001/archpedi.158.2.119.

    PMID: 14757603RESULT

  • Sheeran P, Jafri H, Carubelli C, Saavedra J, Johnson C, Krisher K, Sanchez PJ, Ramilo O. Elevated cytokine concentrations in the nasopharyngeal and tracheal secretions of children with respiratory syncytial virus disease. Pediatr Infect Dis J. 1999 Feb;18(2):115-22. doi: 10.1097/00006454-199902000-00007.

    PMID: 10048682RESULT

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    PMID: 8238534RESULT

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    PMID: 1731020RESULT

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    PMID: 3339502RESULT

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    PMID: 8709687RESULT

  • De Boeck K, Van der Aa N, Van Lierde S, Corbeel L, Eeckels R. Respiratory syncytial virus bronchiolitis: a double-blind dexamethasone efficacy study. J Pediatr. 1997 Dec;131(6):919-21. doi: 10.1016/s0022-3476(97)70044-1.

    PMID: 9427901RESULT

  • Klassen TP, Sutcliffe T, Watters LK, Wells GA, Allen UD, Li MM. Dexamethasone in salbutamol-treated inpatients with acute bronchiolitis: a randomized, controlled trial. J Pediatr. 1997 Feb;130(2):191-6. doi: 10.1016/s0022-3476(97)70342-1.

    PMID: 9042119RESULT

  • Berger I, Argaman Z, Schwartz SB, Segal E, Kiderman A, Branski D, Kerem E. Efficacy of corticosteroids in acute bronchiolitis: short-term and long-term follow-up. Pediatr Pulmonol. 1998 Sep;26(3):162-6. doi: 10.1002/(sici)1099-0496(199809)26:33.0.co;2-n.

    PMID: 9773910RESULT

  • Schuh S, Coates AL, Binnie R, Allin T, Goia C, Corey M, Dick PT. Efficacy of oral dexamethasone in outpatients with acute bronchiolitis. J Pediatr. 2002 Jan;140(1):27-32. doi: 10.1067/mpd.2002.120271.

    PMID: 11815760RESULT

  • Maayan C, Itzhaki T, Bar-Yishay E, Gross S, Tal A, Godfrey S. The functional response of infants with persistent wheezing to nebulized beclomethasone dipropionate. Pediatr Pulmonol. 1986 Jan-Feb;2(1):9-14. doi: 10.1002/ppul.1950020106.

    PMID: 3513105RESULT

  • Reijonen T, Korppi M, Kuikka L, Remes K. Anti-inflammatory therapy reduces wheezing after bronchiolitis. Arch Pediatr Adolesc Med. 1996 May;150(5):512-7. doi: 10.1001/archpedi.1996.02170300066013.

    PMID: 8620234RESULT

  • Carlsen KH, Leegaard J, Larsen S, Orstavik I. Nebulised beclomethasone dipropionate in recurrent obstructive episodes after acute bronchiolitis. Arch Dis Child. 1988 Dec;63(12):1428-33. doi: 10.1136/adc.63.12.1428.

    PMID: 3069051RESULT

  • Noah TL, Wortman IA, Becker S. The effect of fluticasone propionate on respiratory syncytial virus-induced chemokine release by a human bronchial epithelial cell line. Immunopharmacology. 1998 Jun;39(3):193-9. doi: 10.1016/s0162-3109(98)00017-4.

    PMID: 9754905RESULT

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    PMID: 6129609RESULT

MeSH Terms

Conditions

Bronchiolitis

Interventions

dexamethasone acetate

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator.

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 19, 2018

Study Start

February 1, 2019

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

January 9, 2019

Record last verified: 2019-01