Comparison of 3% Normal Saline Nebulization Versus Steroid Nebulization in the Treatment of Bronchiolitis

NCT06139029 | Completed Early Phase 1 DMC

• 1 other identifier: 284/BKMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy of 3% normal saline nebulization and steroid nebulization in the treatment of bronchiolitis in infants.

Conditions

Acute Bronchiolitis

Keywords

3% normal saline; Bronchiolitis; Nebulization; Steroids.; Pediatric intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients in Group-A were nebulized with 3% normal saline

EXPERIMENTAL

Patients in Group-A were nebulized with 3% normal saline 3 times a day at intervals of 8 hours until they improved enough for discharge

Drug: 3% normal saline

patients in Group-B were nebulized with steroid and salbutamol with 0.9% normal saline

EXPERIMENTAL

patients in Group-B were nebulized with steroid (beclomethasone dipropionate 400 μg/day in 3 divided doses) and salbutamol with 0.9% normal saline 3 times a day at intervals of 8 hours until they improved enough for discharge

Drug: steroid(beclomethasone dipropionate 400 μg/day) and salbutamol with 0.9% normal saline

Interventions

3% normal saline DRUG

nebulization

Patients in Group-A were nebulized with 3% normal saline

steroid(beclomethasone dipropionate 400 μg/day) and salbutamol with 0.9% normal saline DRUG

nebulization

patients in Group-B were nebulized with steroid and salbutamol with 0.9% normal saline

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 3 to 12 months
• both genders
• acute brochiolitis as defined

You may not qualify if:

• prior history of wheezing
• family history of asthma
• pneumonia
• progressive respiratory distress requiring mechanical ventillation
• underlying diseases (e-g cystic fibrosis, bronchopulmonary dysplasia and cardiac or renal disease)

Sponsors & Collaborators

• Mardan Medical Complex: lead

Study Sites (1)

Faizan Sadiq

Mardan, Kpk, Pakistan

Location

Related Publications (12)

• 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.

  PMID: 30645038 BACKGROUND

• 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.

  PMID: 30541607 BACKGROUND

• Gold J, Hametz P, Sen AI, Maykowski P, Leone N, Lee DS, Gagliardo C, Hymes S, Biller R, Saiman L. Provider Knowledge, Attitudes, and Practices Regarding Bronchiolitis and Pneumonia Guidelines. Hosp Pediatr. 2019 Feb;9(2):87-91. doi: 10.1542/hpeds.2018-0211. Epub 2019 Jan 4.

  PMID: 30610012 BACKGROUND

• 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.

  PMID: 30772962 BACKGROUND

• Skjerven HO, Megremis S, Papadopoulos NG, Mowinckel P, Carlsen KH, Lodrup Carlsen KC; ORAACLE Study Group. Virus Type and Genomic Load in Acute Bronchiolitis: Severity and Treatment Response With Inhaled Adrenaline. J Infect Dis. 2016 Mar 15;213(6):915-21. doi: 10.1093/infdis/jiv513. Epub 2015 Oct 27.

  PMID: 26508124 BACKGROUND

• Heppe Montero M, Gil-Prieto R, Walter S, Aleixandre Blanquer F, Gil De Miguel A. Burden of severe bronchiolitis in children up to 2 years of age in Spain from 2012 to 2017. Hum Vaccin Immunother. 2022 Dec 31;18(1):1883379. doi: 10.1080/21645515.2021.1883379. Epub 2021 Mar 2.

  PMID: 33653212 BACKGROUND

• 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.

  PMID: 27509268 BACKGROUND

• 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.

  PMID: 28572120 BACKGROUND

• 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.

  PMID: 35598608 BACKGROUND

• 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.

  PMID: 28470580 BACKGROUND

• Jo YM, Kim J, Chang J. Vaccine containing G protein fragment and recombinant baculovirus expressing M2 protein induces protective immunity to respiratory syncytial virus. Clin Exp Vaccine Res. 2019 Jan;8(1):43-53. doi: 10.7774/cevr.2019.8.1.43. Epub 2019 Jan 31.

  PMID: 30775350 BACKGROUND

• 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.

  PMID: 30783666 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution; Albuterol

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• faizan sadiq, MBBS

  Mardan Medical Complex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: faizan sadiq,principal investigator, post graduate resident in pediatrics

Model Details: This randomized controlled trial was conducted at the Department of Pediatrics, Mardan Medical Complex, Mardan over a period of 4 months from 15th of November 2022 to 15th of March 2023. Sample size was calculated with OpenEpi calculator using 95% confidence level and power 80%. Estimated sample size 60, n1 (Patients in Group-A) =30, n2 (Patients in Group-B) =30. A total of 60 infants from both the genders between the ages of 3 to 12 months admitted in the pediatric unit with bronchiolitis were included in this study through non-probability consecutive sampling and equally randomized into 2 groups. Exclusion Criteria was set as infants having some underlying disease (e.g. Cystic fibrosis, bronchopulmonary dysplasia and cardiac or renal disease), prior history of wheezing, family history of asthma, pneumonia, TB, allergic history and progressive respira

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 18, 2023
• Study Start: November 15, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 weeks

Locations

PA (1)