Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Bronchiolitis.
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|ClinicalTrials.gov Identifier: NCT01276821|
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Drug: L-Epinephrine and Normal Saline (0.9%) Drug: L-Epinephrine and Hypertonic Saline (3%)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Nebulised Hypertonic Saline (3%) Among Children With Mild to Moderately Severe Bronchiolitis - A Double Blind Randomized Controlled Trial.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Placebo Comparator: Standard Treatment
L-Epinephrine and Normal Saline (0.9%)
Drug: L-Epinephrine and Normal Saline (0.9%)
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
Active Comparator: Study Treatment
L-Epinephrine and Hypertonic Saline (3%)
Drug: L-Epinephrine and Hypertonic Saline (3%)
1.5ml of 1:1,000 L-Epinephrine and 4 ml of 3% Hypertonic Saline
Other Name: Nebulised Epinephrine in 3% Hypertonic Saline
- Mean Change in Clinical Severity Score [ Time Frame: 2 hours ]
Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline.
Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children.
The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa.
The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992).
This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale.
- Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation [ Time Frame: At the end of 2 hours ]
- Relapse Rate [ Time Frame: 24 hours ]To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit
- Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week [ Time Frame: 7 days ]
- Missed Days of Work of Caregivers [ Time Frame: 7 days ]Number of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call.
- Persistence of Cough at the End of 1 Week [ Time Frame: 7 days ]Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children.
- Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy. [ Time Frame: 2 hours ]The outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results.
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): NCT01276821
|Out Patient Department and Emergency Department, Kanti Children Hospital|
|Kathmandu, Bagmati Zone, Nepal, 44600|
|Principal Investigator:||Aayush Khanal, MD||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.|
|Study Chair:||Fakir C Gami, MD||Department of Child Health, Tribhuvan University Teaching Hospital, Institute of Medicine.|