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Intravenous Magnesium in Wheezy Bronchitis

Primary Purpose

Wheezy Bronchitis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Magnesium Sulfate
Placebo
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wheezy Bronchitis focused on measuring wheezy bronchitis, asthma, rhinovirus, magnesium

Eligibility Criteria

6 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 0.5 - 4 years
  • wheezy bronchitis
  • RDAI > 6 after conventional treatment

Exclusion Criteria:

  • prematurity
  • congenital heart disease
  • immune deficiency

Sites / Locations

  • Department of Pediatrics, Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magnesium

Placebo

Arm Description

i.v. magnesium infusion 40mg/kg in 20 min

i.v. 0.9 % NaCl

Outcomes

Primary Outcome Measures

RDAI score

Secondary Outcome Measures

saturation
RDAI
saturation
length of hospital stay

Full Information

First Posted
June 6, 2011
Last Updated
January 20, 2016
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT01383655
Brief Title
Intravenous Magnesium in Wheezy Bronchitis
Official Title
The Efficacy of Intravenous Magnesium in Acute Wheezy Bronchitis in Small Children - a Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always satisfactory. The purpose of this trial is to investigate the effectiveness of iv-magnesium in the treatment of moderate or severe bronchial obstruction associated with viral infection in small children. The study population will include the children attending the Pediatric Emergency Department of Oulu University Hospital because of respiratory infection and bronchial obstruction that is not relieved with conventional treatment. After written consent from the parents, the children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points and length of hospital stay. The sample size is 64 children at the age of 6 months to 4 years. If iv-magnesium is effective in relieving viral infection associated bronchial obstruction, that would be an important addition to the treatment of this common disease.
Detailed Description
In infants and toddlers wheezy bronchitis is a common viral disease. To relieve wheezing symptoms bronchodilators or corticosteroids are commonly used but the efficacy is not always satisfactory. Intravenous infusion of magnesium sulfate has been proven to be efficacious and safe for the treatment of acute asthma attacks in adults and school-aged children. The purpose of this trial is to investigate the effectiveness of iv-magnesium in the treatment of moderate or severe bronchial obstruction associated with viral infection in small children. The study population will include the children attending the Pediatric Emergency Department of Oulu University Hospital because of respiratory infection and bronchial obstruction that is not relieved with conventional treatment. After written consent from the parents, the children will be randomized to get either intravenous magnesium sulfate or isotonic NaCl. The primary outcome is RDAI (Respiratory Distress Assessment Instrument) scoring six hours from the infusion. Secondary endpoints are RDAI scoring and oxygen saturation at other time points and length of hospital stay. The sample size is 64 children at the age of 6 months to 4 years. If iv-magnesium is effective in relieving viral infection associated bronchial obstruction, that would be an important addition to the treatment of this common disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheezy Bronchitis
Keywords
wheezy bronchitis, asthma, rhinovirus, magnesium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium
Arm Type
Experimental
Arm Description
i.v. magnesium infusion 40mg/kg in 20 min
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
i.v. 0.9 % NaCl
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
i.v. magnesium 40mg/kg in 20 min
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
NaCl
Primary Outcome Measure Information:
Title
RDAI score
Time Frame
6h
Secondary Outcome Measure Information:
Title
saturation
Time Frame
6h
Title
RDAI
Time Frame
2h
Title
saturation
Time Frame
2h
Title
length of hospital stay
Time Frame
length of hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 0.5 - 4 years wheezy bronchitis RDAI > 6 after conventional treatment Exclusion Criteria: prematurity congenital heart disease immune deficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjo Renko, MD
Organizational Affiliation
University of Oulu, Department of Pediatrics
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pediatrics, Oulu University Hospital
City
Oulu
ZIP/Postal Code
90230
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29437941
Citation
Pruikkonen H, Tapiainen T, Kallio M, Dunder T, Pokka T, Uhari M, Renko M. Intravenous magnesium sulfate for acute wheezing in young children: a randomised double-blind trial. Eur Respir J. 2018 Feb 7;51(2):1701579. doi: 10.1183/13993003.01579-2017. Print 2018 Feb.
Results Reference
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Intravenous Magnesium in Wheezy Bronchitis

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