NCT02145520

Brief Summary

In this study, investigators will compare the efficacy and safety of intravenous (IV) Magnesium sulfate in decreasing bronchiolitis clinical severity score and the duration of hospitalization in admitted patients, as compared to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 16, 2016

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

January 28, 2014

Last Update Submit

August 14, 2016

Conditions

BronchiolitisMagnesium, Abnormal Blood Level

Keywords

bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • Improvement Percentage of Discharge After a Dose of IV Magnesium sulfate

    Time to medical readiness for discharge

Secondary Outcomes (1)

  • Improvement of bronchiolitis clinical severity score

    2 Weeks

Study Arms (2)

Magnesium sulfate

EXPERIMENTAL

Magnesium sulfate. Single dose intravenous over one hour.

Drug: Magnesium Sulfate

placebo

PLACEBO COMPARATOR

Treatment will be delivered to enrolled patients as currently practice in PEC (Epinephrine nebulization +5%hypertonic saline with/without dexamethasone). •All patients will be randomized to receive either Magnesium sulfate over 1 hour or placebo.•Bronchiolitis severity score (BSS) will be recorded at 0, 4, 8, 12, 16,20,24,36,48,60,72 hours, and on discharge.

Other: placebo

Interventions

Magnesium SulfateDRUG

The use of magnesium sulfate intravenous in patient with bronchiolitis in pediatric emergency; follow Broncholitis severity score and length of stay

Magnesium sulfate
placeboOTHER

use of placebo with standard therapy

Also known as: normal saline for intravenous.
placebo

Eligibility Criteria

Age1 Month - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants 1-18 months of age presenting to Al Saad Pediatric Emergency Center from October 2012 to May 2015 with diagnosis of Bronchiolitis and bronchiolitis clinical severity score \> 4,will be include in the study.

You may not qualify if:

  • Prematurity (Gestational age 34 weeks or less);
  • Previous history of wheezing;
  • Use of steroid within 48 hours of presentation;
  • CRITICALLY ill patients with one or more of the following:
  • obtunded consciousness
  • progressive respiratory failure requiring intensive care unit (PICU) admission;
  • history of apnea within 24 hours before presentation
  • oxygen saturation \< 85% on room air at the time of recruitment
  • History of chronic lung disease;Chronic lung disease of prematurity Cystic fibrosis;
  • Congenital heart disease.
  • All immunodeficient children: primary or secondary
  • Known hypersensitivity to magnesium sulfate.
  • Known to have magnesium or calcium metabolism disturbance. (e.g.; vitamin D deficiency, hypoparathyroidism).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Emergency Center, Al Saad

Doha, Qatar, 465934, Qatar

Location

Related Publications (1)

  • Alansari K, Sayyed R, Davidson BL, Al Jawala S, Ghadier M. IV Magnesium Sulfate for Bronchiolitis: A Randomized Trial. Chest. 2017 Jul;152(1):113-119. doi: 10.1016/j.chest.2017.03.002. Epub 2017 Mar 9.

    PMID: 28286262DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Khalid M Al-Ansai, MD

    HMC

    PRINCIPAL INVESTIGATOR

  • Rafah F Sayyed, MD

    HMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

May 23, 2014

Study Start

October 1, 2012

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

August 16, 2016

Record last verified: 2015-03

Locations

QA(1)