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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00696540 |
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Date of registration:
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09/06/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hypertonic Saline for Outpatient Bronchiolitis
Hypertonic |
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Scientific title:
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Safety and Efficacy of Hypertonic Vrs. Normal Saline as Diluent of Salbutamol to Reduce Respiratory Distress in Outpatients With the Clinical Diagnosis of Bronchiolitis During the RSV Epidemic. |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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74 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00696540 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Chile
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Contacts
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Name:
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Irmeli Roine, MD, PhD |
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Address:
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Telephone:
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+56-2-6762916 |
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Email:
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irmeli.roine@prof.udp.cl |
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Affiliation:
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Name:
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Ricardo Mercado, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinica Vespucio, Santiago, Chile |
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Name:
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Ricardo Mercado, MD |
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Address:
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Telephone:
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+56-2-8206500 |
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Email:
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rmercado@ssmso.cl |
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Affiliation:
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Name:
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Irmeli Roine, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Diego Portales |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 1 to 24 months
2. Mild to moderate respiratory distress (Tal score below 9)
3. Up to 5 days of respiratory symptoms, including today
4. Expiratory wheezing heard on chest auscultation
5. Indication of salbutamol nebulization treatment by attending physician
Exclusion Criteria:
1. Two prior episodes of wheezing
2. Premature birth (below 38 weeks), if below 6 months of age
3. Lobar pneumonia
4. Body temperature above 38 degree Celsius
5. Use of salbutamol during the previous 6 hours
6. Pulse oxymetry reading below 90%
7. Congenital heart disease
8. Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
9. Other chronic or genetic condition or disease
Age minimum:
1 Month
Age maximum:
24 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bronchiolitis
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Respiratory Distress
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Intervention(s)
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Drug: Inhalation of salbutamol diluted in normal saline
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Drug: Inhalation of salbutamol diluted in hypertonic saline
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Primary Outcome(s)
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Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
[Time Frame: 1 hour]
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Secondary Outcome(s)
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Change in pulse oxymetry reading between the basal score and after each of the three nebulizations
[Time Frame: 1 hour]
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Change in the respiratory distress score (Tal) between the basal score and the first nebulization
[Time Frame: 15 to 20 minutes]
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Change in the respiratory distress score (Tal) between the basal score and the second nebulization
[Time Frame: 15 to 20 minutes after the first nebulization]
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Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization
[Time Frame: 1 hour]
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Secondary ID(s)
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UDP-CT1-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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