Epinephrine, Dexamethasone, and Hypertonic Saline in Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety
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| ClinicalTrials.gov Identifier: NCT01834820 |
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Recruitment Status :
Completed
First Posted : April 18, 2013
Last Update Posted : July 8, 2015
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Sponsor:
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Information provided by (Responsible Party):
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
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Brief Summary:
In infancy, bronchiolitis is the most common acute infection of the lower respiratory Tract. The current treatment of bronchiolitis is controversial. Bronchodilators and corticosteroids are widely used but not routinely recommended. Hypertonic saline is currently the only drug recommended by the Spanish Association of Pediatrics in treatment guidelines.
The purpose of this study is quantify whether epinephrine, dexamethasone, and hypertonic saline are effective to decrease the rate of hospital admissions at seven day, also verify adverse effects in patients submitted.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchiolitis | Drug: Epinephrine and Dexamethasone Drug: Hypertonic Saline Drug: Normal Saline | Phase 4 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Health Services Research |
| Official Title: | Pilot Study: Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis, Randomised Clinical Trial of Efficacy and Safety |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Epinephrine and Dexamethasone
First day: One treatment of nebulized dexamethasone 4mg (1ml of dexamethasone 8mg/2ml) + 3ml NS, followed by two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) with interval 20 minutes. And one treatment of nebulized dexamethasone every 24h for three days.
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Drug: Epinephrine and Dexamethasone |
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Experimental: Hypertonic Saline 3%
3 treatments of nebulized HS 3% 4ml in first day of treatment with interval 20 minutes And one treatment of nebulized HS 3% 4ml every 24 hours for 3 days
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Drug: Hypertonic Saline |
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Active Comparator: Normal Saline 0.9%
3 treatments of nebulized Normal Saline 0.9% 4ml in first day of treatment with interval 20 minutes. And one treatment of nebulized Normal Saline 0.9% 4ml every 24 hours for 3 days
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Drug: Normal Saline |
Primary Outcome Measures :
- Rate of hospital admissions at seven day in infants whit bronchiolitis. [ Time Frame: From date of randomization until the day seven of treatment ]Tracking each patient until 7 days after treatment to verify hospitalization rate
Secondary Outcome Measures :
- Number of participants with adverse events in each arm of treatment [ Time Frame: From date of randomization until the seven day of treatment ]
Other Outcome Measures:
- Change from baseline CBSS after three treatments in the first day [ Time Frame: First day of treatment ]Each patient on admission to the emergency department with a diagnosis of mild to moderate bronchiolitis were taken CBSS baseline, then at 20 minutes after completion three nebulized treatment in the first day.
- Change from baseline heart rate after three treatments in the first day [ Time Frame: First day of treatment ]Each patient on admission to the emergency department with a diagnosis of mild to moderate bronchiolitis were taken heart rate, then at 20 minutes after completion three nebulized treatment in the first day.
- Change from baseline oxygen saturation after three treatments in the first day [ Time Frame: First day of treatment ]Each patient on admission to the emergency department with a diagnosis of mild to moderate bronchiolitis were taken oxygen saturation, then at 20 minutes after completion three nebulized treatment in the first day.
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| Ages Eligible for Study: | 2 Months to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients under 2 years of age diagnosed with bronchiolitis
- Be beneficiaries Marine
- Outpatient
- Severity of Bronchiolitis mild to moderate scale according to Wood-Downes
Exclusion Criteria:
- Patients with a history of atopy
- Patients with a history of asthma in infants
- Patients with serious bacterial illness criteria
- Patients with comorbidity
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834820
Locations
| Mexico | |
| Hospital General Naval de Alta Especialidad | |
| México, Distrito Federal, Distrito Federal, Mexico, 04480 | |
Sponsors and Collaborators
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Investigators
| Principal Investigator: | José Luis Rodríguez Cuevas, pediatrician |
Publications of Results:
Cantón SBF, Trujillo GG, Uribe RV. Principales causas de mortalidad infantil en México: tendencias recientes. Bol Med Hosp Infant Mex. 2012;69(2):144-8.
Cincinnati Children's Hospital Medical Center. Evidence-based care guideline for management of first time episode bronchiolitis in infants less than 1 year of age.
Other Publications:
Intercollegiate S, Network G. Bronchiolitis in children. (SIGN Guideline No 91). 2006;(november).
Acosta A et all. Diagnóstico y manejo en niños con Bronquiolitis en fase aguda, México: Secretaria de Salud. Catálogo maestro de Guías de práctica clínica: IMSS -032-08. 2010
| Responsible Party: | Hospital General Naval de Alta Especialidad - Escuela Medico Naval |
| ClinicalTrials.gov Identifier: | NCT01834820 History of Changes |
| Other Study ID Numbers: |
HGNAE-01 |
| First Posted: | April 18, 2013 Key Record Dates |
| Last Update Posted: | July 8, 2015 |
| Last Verified: | July 2015 |
Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:
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Bronchiolitis Epinephrine Dexamethasone Hospitalization Hypertonic Saline |
Additional relevant MeSH terms:
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Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Dexamethasone acetate Dexamethasone Epinephrine Racepinephrine Epinephryl borate BB 1101 Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |