Assessment of the Efficacy of Nebulised 3% Hypertonic Saline Among Infants Aged 6 Weeks- 24 Months With Bronchiolitis
This study has been completed.
Sponsor:
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Information provided by:
Tribhuvan University Teaching Hospital, Institute Of Medicine.
ClinicalTrials.gov Identifier:
NCT01276821
First received: January 12, 2011
Last updated: May 31, 2011
Last verified: January 2011
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Purpose
To assess the efficacy of nebulized 3% hypertonic saline in improving clinical severity scores among infants aged 6 weeks to 24 months with bronchiolitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchiolitis |
Drug: L-Epinephrine and 0.9% Normal Saline Drug: L-Epinephrine and 3% Hypertonic Saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Assessment of the Efficacy of Nebulised 3% Hypertonic Saline Among Infants Aged 6 Weeks - 24 Months With Bronchiolitis. |
Resource links provided by NLM:
Drug Information available for:
Epinephrine bitartrate
Epinephrine
Epinephrine hydrochloride
Racepinephrine hydrochloride
Racepinephrine
U.S. FDA Resources
Further study details as provided by Tribhuvan University Teaching Hospital, Institute Of Medicine.:
Primary Outcome Measures:
- Mean Change in Clinical Severity Score [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of Patients having need for Hospital Admission [ Time Frame: At the end of 2 hours ] [ Designated as safety issue: No ]
| Enrollment: | 98 |
| Study Start Date: | January 2011 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Standard |
Drug: L-Epinephrine and 0.9% Normal Saline
1.5ml of 1:1,000 L-Epinephrine and 4 ml of 0.9% Normal Saline
Other Name: Nebulised Epinephrine in 0.9% Normal saline
|
| Experimental: Study |
Drug: L-Epinephrine and 3% Hypertonic Saline
1.5ml of 1:1,000 L-Epinephrine and 4 ml of 3% Hypertonic Saline
Other Name: Nebulised Epinephrine in 3% Hypertonic Saline
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 6 Weeks to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Infants aged 6 weeks to 24 Months.
- First episode of wheezing
- Fever, cough and watery nasal discharge
Exclusion Criteria :
- Any underlying disease (e.g., cystic fibrosis, bronchopulmonary dysplasia cardiac or renal disease).
- Prior history of wheezing.
- Clinical Severity Score > 9
- Atopic dermatitis, allergic rhinitis or asthma,
- oxygen saturation (SaO2) <80% on room air.
- obtunded consciousness, progressive respiratory failure requiring mechanical ventilation
- Previous treatment with bronchodilators within 4 hours.
- Any steroid therapy within 48 Hours.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276821
Locations
| Nepal | |
| Out Patient Department and Emergency Department, Kanti Children Hospital | |
| Kathmandu, Bagmati Zone, Nepal, 44600 | |
Sponsors and Collaborators
Tribhuvan University Teaching Hospital, Institute Of Medicine.
Investigators
| Principal Investigator: | Aayush Khanal, MD Resident | Department of Child Health , Institute of Medicine , Tribhuvan University Teaching Hospital. |
| Study Director: | Arun Sharma, MD | Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine, Maharajgunj, Kathmandu ,Nepal. |
| Study Director: | Srijana Basnet, MD | Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine , Maharajgunj , Kathmandu , Nepal. |
| Study Chair: | Pushpa R Sharma, DCH,FCPS | Head of the Department. Department of Child Health , Tribhuvan University Teaching Hospital , Institute of Medicine , Maharajgunj , Kathmandu , Nepal. |
More Information
No publications provided
| Responsible Party: | Dr. Aayush Khanal., MD Resident, 3rd Year, Department Of Child Health,TUTH,IOM. |
| ClinicalTrials.gov Identifier: | NCT01276821 History of Changes |
| Other Study ID Numbers: | PEDSTUTHIOM |
| Study First Received: | January 12, 2011 |
| Last Updated: | May 31, 2011 |
| Health Authority: | Nepal: Health Research Council |
Keywords provided by Tribhuvan University Teaching Hospital, Institute Of Medicine.:
|
Bronchiolitis L-Epinephrine 3% Hypertonic Saline Clinical Severity Score |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Epinephrine Epinephryl borate Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013