Intravenous Magnesium in Wheezy Bronchitis | NCT01383655

Studies
Intravenous Magnesium in Wheezy Bronchitis

NCT01383655

Sponsor

University of Oulu

Status

Completed

Last Update Posted

Jan 21, 2016Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Wheezy Bronchitis

Interventions

Magnesium Sulfate
Placebo

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jun 6, 2011

First Submission Date that Met QC Criteria

Jun 27, 2011

First Posted Date

Jun 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2016

Last Update Posted Date

Jan 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marjo Renko, docent, University of OuluPrincipal Investigator

Lead Sponsor

University of OuluOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesium	Experimental	i.v. magnesium infusion 40mg/kg in 20 min	Drug: Magnesium Sulfate
Placebo	Placebo Comparator	i.v. 0.9 % NaCl	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate	Drug	i.v. magnesium 40mg/kg in 20 min	Magnesium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RDAI score		6h

Secondary Outcomes

Measure	Description	Time Frame
saturation		6h
RDAI		2h
saturation		2h

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

prematurity
congenital heart disease
immune deficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

4 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marjo Renko, MD	University of Oulu, Department of Pediatrics	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Oulu University Hospital		Oulu	Oulu	90230	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29437941	Derived	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.

ID	Term
D001988	Bronchiolitis
D001249	Asthma

ID	Term
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids