Non-invasive Ventilation vs. Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma

NCT03296579 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-05-02

No results posted yet for this study

Summary

Acute asthma produces greatly increased work of breathing and increased oxygen requirement secondary to bronchial narrowing and airway obstruction by inflammatory secretions. There is growing evidence that non-invasive ventilation can reverse these processes more efficiently than conventional asthma therapy. Surprisingly, there have not yet been any large scale prospective controlled studies to investigate this hypothesis, (either in adults or children). Consequently, the aim of this study is to determine if the use of non-invasive positive airway pressure, for children admitted to hospital with an acute exacerbation of asthma, reduces their work of breathing, need for adjunctive medications, and shortens the length of hospital stay, compared to current standard therapy.

Conditions

  • Asthma Acute
  • Asthma in Children

Interventions

DEVICE

BiPAP

The patient's breathing is assisted by cycling between high and low pressures at a pre-set rate.

DEVICE

CPAP

The patient breathes against a constant pressure delivered by face mask.

DRUG

Ipratropium

Nebulized q6h

DRUG

Magnesium Sulfate

50mg/kg IV, 4 doses q6h

DRUG

Aminophylline

6mg/kg IV (if no progress)

DRUG

Standard steroid dose, hourly salbutamol, oxygen as needed

Standard common therapies for all three arms.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    collaborator OTHER
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Michael Seear · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2018-11-30
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296579 on ClinicalTrials.gov