NCT03190759

Brief Summary

Asthma is a heterogeneous disease, usually characterized by chronic airway inflammation. It is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiatory airflow limitation. This definition was reached by consensus, based on consideration of the characteristics that are typical of asthma and that distinguish it from other respiratory conditions . Asthma is a problem worldwide, with an estimated 300 million affected individuals .It appears that the global prevalence of asthma ranges from 1% to 18% of the population in different countries .

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
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

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

June 10, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

November 11, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2018

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

1 month

First QC Date

June 10, 2017

Last Update Submit

June 15, 2017

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

  • ICU admission according to oxygen saturation <81%, respiratory rate <6years old = >60 ≥6years old = >50 and heart rate <3 years old = >160 ≥3 years old= >140

    Adequate evaluation of the severity of asthma exacerbation is important for the initial management of patients,using clinical parameters to decide ICU admission :oxygen saturation ,heart rate,respiratory rate and Degree of agitation and conscious level.

    within 15 minute

Secondary Outcomes (1)

  • hospital stay

    within one week

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

all patient admitted to emergency department of assiut university within three months of winter of anticipated number 60

You may qualify if:

  • children with acute asthma exacerbation
  • children with acute asthma aged 1-17 years old
  • background history of asthma
  • this study will deal with the protocols applied in Assiut university children hospital

You may not qualify if:

  • children below age of 1 year and more than 17 years old
  • Known Tuberculosis exposure
  • concurrent stridor
  • use of oral corticosteroids in the previous four weeks
  • Significant co-morbid disease : lung ,cardiac ,immune , liver , endocrine ,neurological or psychiatric
  • children with other causes of respiratory distress
  • Children with mild or controlled asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Becker AB, Nelson NA, Simons FE. The pulmonary index. Assessment of a clinical score for asthma. Am J Dis Child. 1984 Jun;138(6):574-6. doi: 10.1001/archpedi.1984.02140440058015.

    PMID: 6720644RESULT

  • Gorelick MH, Stevens MW, Schultz TR, Scribano PV. Performance of a novel clinical score, the Pediatric Asthma Severity Score (PASS), in the evaluation of acute asthma. Acad Emerg Med. 2004 Jan;11(1):10-8. doi: 10.1197/j.aem.2003.07.015.

    PMID: 14709423RESULT

  • Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469-78. doi: 10.1111/j.1398-9995.2004.00526.x. No abstract available.

    PMID: 15080825RESULT

  • Smith SR, Baty JD, Hodge D 3rd. Validation of the pulmonary score: an asthma severity score for children. Acad Emerg Med. 2002 Feb;9(2):99-104. doi: 10.1111/j.1553-2712.2002.tb00223.x.

    PMID: 11825832RESULT

  • van der Windt D. Promises and pitfalls in the evaluation of pediatric asthma scores. J Pediatr. 2000 Dec;137(6):744-6. doi: 10.1067/mpd.2000.111458. No abstract available.

    PMID: 11113827RESULT

  • Weiss KB, Wagener DK. Changing patterns of asthma mortality. Identifying target populations at high risk. JAMA. 1990 Oct 3;264(13):1683-7.

    PMID: 2398607RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

. Moustafa El -Said, Professor

CONTACT

01110277000moustafa13@yahoo.com

Eman askar, Assistant

CONTACT

01099696173emanAsker@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicpal investigator

Study Record Dates

First Submitted

June 10, 2017

First Posted

June 19, 2017

Study Start

November 11, 2017

Primary Completion

December 22, 2017

Study Completion

October 20, 2018

Last Updated

June 19, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share