Acute Bronchiolitis Clinical Trial
Official title:
Comparison of 3% Normal Saline Nebulization Versus Steroid Nebulization in the Treatment of Bronchiolitis
Verified date | November 2023 |
Source | Mardan Medical Complex |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the efficacy of 3% normal saline nebulization and steroid nebulization in the treatment of bronchiolitis in infants.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 15, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 12 Months |
Eligibility | inclusion 1. age 3 to 12 months 2. both genders 3. acute brochiolitis as defined exclusion 1. prior history of wheezing 2. family history of asthma 3. pneumonia 4. TB 5. progressive respiratory distress requiring mechanical ventillation 6. underlying diseases (e-g cystic fibrosis, bronchopulmonary dysplasia and cardiac or renal disease) |
Country | Name | City | State |
---|---|---|---|
Pakistan | Faizan Sadiq | Mardan | Kpk |
Lead Sponsor | Collaborator |
---|---|
Mardan Medical Complex |
Pakistan,
Fretzayas A, Moustaki M. Etiology and clinical features of viral bronchiolitis in infancy. World J Pediatr. 2017 Aug;13(4):293-299. doi: 10.1007/s12519-017-0031-8. Epub 2017 May 4. — View Citation
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Li Y, Wang X, Blau DM, Caballero MT, Feikin DR, Gill CJ, Madhi SA, Omer SB, Simoes EAF, Campbell H, Pariente AB, Bardach D, Bassat Q, Casalegno JS, Chakhunashvili G, Crawford N, Danilenko D, Do LAH, Echavarria M, Gentile A, Gordon A, Heikkinen T, Huang QS, Jullien S, Krishnan A, Lopez EL, Markic J, Mira-Iglesias A, Moore HC, Moyes J, Mwananyanda L, Nokes DJ, Noordeen F, Obodai E, Palani N, Romero C, Salimi V, Satav A, Seo E, Shchomak Z, Singleton R, Stolyarov K, Stoszek SK, von Gottberg A, Wurzel D, Yoshida LM, Yung CF, Zar HJ; Respiratory Virus Global Epidemiology Network; Nair H; RESCEU investigators. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022 May 28;399(10340):2047-2064. doi: 10.1016/S0140-6736(22)00478-0. Epub 2022 May 19. — View Citation
Oz-Alcalay L, Ashkenazi S, Glatman-Freedman A, Weisman-Demri S, Lowenthal A, Livni G. Hospitalization for Respiratory Syncytial Virus Bronchiolitis in the Palivizumab Prophylaxis Era: Need for Reconsideration of Preventive Timing and Eligibility. Isr Med Assoc J. 2019 Feb;21(2):110-115. — View Citation
Panda S, Mohakud NK, Suar M, Kumar S. Etiology, seasonality, and clinical characteristics of respiratory viruses in children with respiratory tract infections in Eastern India (Bhubaneswar, Odisha). J Med Virol. 2017 Mar;89(3):553-558. doi: 10.1002/jmv.24661. Epub 2016 Aug 22. — View Citation
Picone S, Fabiano A, Roma D, Di Palma F, Paolillo P. Re-comparing of three different epidemic seasons of bronchiolitis: different prophylaxis approaches. Ital J Pediatr. 2018 Dec 12;44(1):148. doi: 10.1186/s13052-018-0593-7. — View Citation
Polack FP, Stein RT, Custovic A. The Syndrome We Agreed to Call Bronchiolitis. J Infect Dis. 2019 Jun 19;220(2):184-186. doi: 10.1093/infdis/jiz082. — View Citation
Schlapbach LJ, Straney L, Gelbart B, Alexander J, Franklin D, Beca J, Whitty JA, Ganu S, Wilkins B, Slater A, Croston E, Erickson S, Schibler A; Australian & New Zealand Intensive Care Society (ANZICS) Centre for Outcomes & Resource Evaluation (CORE) and the Australian & New Zealand Intensive Care Society (ANZICS) Paediatric Study Group. Burden of disease and change in practice in critically ill infants with bronchiolitis. Eur Respir J. 2017 Jun 1;49(6):1601648. doi: 10.1183/13993003.01648-2016. Print 2017 Jun. — View Citation
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Stobbelaar K, Kool M, de Kruijf D, Van Hoorenbeeck K, Jorens P, De Dooy J, Verhulst S. Nebulised hypertonic saline in children with bronchiolitis admitted to the paediatric intensive care unit: A retrospective study. J Paediatr Child Health. 2019 Sep;55(9):1125-1132. doi: 10.1111/jpc.14371. Epub 2019 Jan 6. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy of 3% hypertonic saline in acute brochiolitis | Primary outcome was efficacy of the treatment defined as number of patients discharged from hospital in = 72 hours after start of treatment. Efficacy between the 2 groups was compared by applying the chi-square test, p =0.05 was considered statistically significant. | discharged from hospital in = 72 hours after start of treatment |
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