Wheezy Bronchitis Clinical Trial
Official title:
The Efficacy of Intravenous Magnesium in Acute Wheezy Bronchitis in Small Children - a Randomized, Controlled Study
| Verified date | January 2016 |
| Source | University of Oulu |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Finland: Finnish Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Months to 4 Years |
| Eligibility |
Inclusion Criteria: - age 0.5 - 4 years - wheezy bronchitis - RDAI > 6 after conventional treatment Exclusion Criteria: - prematurity - congenital heart disease - immune deficiency |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Finland | Department of Pediatrics, Oulu University Hospital | Oulu |
| Lead Sponsor | Collaborator |
|---|---|
| University of Oulu |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | RDAI score | 6h | No | |
| Secondary | saturation | 6h | No | |
| Secondary | RDAI | 2h | No | |
| Secondary | saturation | 2h | No | |
| Secondary | length of hospital stay | length of hospital stay | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03199976 -
Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
|
Phase 4 |