Inhaled Hypertonic Saline Use in the Emergency Department to Treat Acute Viral Bronchiolitis

NCT02045238 | Terminated Results

• 1 other identifier: 1263/13 - University Hospital
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Acute viral bronchiolitis is an extremely common childhood disease, responsible for approximately 17% of childhood admissions to hospital per year, with an annually cost that reaches U$ 500 million. Despite being a well known disease among pediatricians, there are few, if any, effective treatment options apart from oxygen supplementation and adequate hydration. The purpose of this study is to determine wether nebulized hypertonic saline (3%) is more effective than normal saline (0,9%) when used in repeated doses during the first 24 hours of in-hospital treatment.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; Therapeutics; Saline Solution, Hypertonic

Outcome Measures

Primary Outcomes (2)

• Rate of Admission

  Patients staying longer than 24h are considered to be admitted to ward.

  24 hours

• Time to Attain Discharge Criteria

  Discharge criteria are: Room air saturation \>94% AND respiratory rate \< 60 AND Respiratory Distress Assessment Instrument (RDAI) score inferior than 4, maintained over a 4 hour period.

  24 hours

Secondary Outcomes (3)

• Time to Discharge

  24 hours

• Rate of Readmission After Discharge

  5 days

• Incidence of Adverse Effects

  24 hours

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.

Radiation: Chest X-Ray; Other: Respiratory virus screening test

Hypertonic Saline

EXPERIMENTAL

Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat\>94% AND respiratory rate \<60 AND RDAI score \<4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.

Drug: Hypertonic Saline; Radiation: Chest X-Ray; Other: Respiratory virus screening test

Interventions

Hypertonic Saline DRUG

Sodium Chloride 3% solution, previously prepared in 5 mL syringes.

Hypertonic Saline

Chest X-Ray RADIATION

Hypertonic Saline; Normal Saline

Respiratory virus screening test OTHER

Immunofluorescence analysis of nasal aspirate

Hypertonic Saline; Normal Saline

Eligibility Criteria

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

You may qualify if:

• Age \< 12 months
• Clinical diagnosis of bronchiolitis (viral respiratory disease and wheezing)
• First episode of wheezing in life
• Moderate respiratory distress, defined as 2 of the following: Sat \<93%, respiratory rate \>60 and/or RDAI score \>4

You may not qualify if:

• Previous episodes of wheezing in history
• Use of bronchodilators, corticosteroids or antibiotics in the 24 hours prior to admission or at any time during treatment.
• Other clinical conditions such as: prematurity, bronchopulmonary dysplasia, cystic fibrosis, cardiac disease or immunodeficiencies.
• detection of alveolar infiltrates suggestive of pneumonia in radiologic examination
• respiratory impairment requiring mechanical ventilation on arrival to hospital.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University Hospital of Sao Paulo University

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (8)

• Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. Pediatr Pulmonol. 2010 Jan;45(1):41-7. doi: 10.1002/ppul.21108.

  PMID: 19953579 BACKGROUND

• Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A, Priel IE. Nebulized 3% hypertonic saline solution treatment in hospitalized infants with viral bronchiolitis. Chest. 2003 Feb;123(2):481-7. doi: 10.1378/chest.123.2.481.

  PMID: 12576370 BACKGROUND

• Kuzik BA, Al-Qadhi SA, Kent S, Flavin MP, Hopman W, Hotte S, Gander S. Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. J Pediatr. 2007 Sep;151(3):266-70, 270.e1. doi: 10.1016/j.jpeds.2007.04.010. Epub 2007 Jun 29.

  PMID: 17719935 BACKGROUND

• Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006458. doi: 10.1002/14651858.CD006458.pub3.

  PMID: 23900970 BACKGROUND

• Principi T, Komar L. A critical review of "a randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department.". J Popul Ther Clin Pharmacol. 2011;18(2):e273-4. Epub 2011 May 16. No abstract available.

  PMID: 21633141 BACKGROUND

• Jacobs JD, Foster M, Wan J, Pershad J. 7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial. Pediatrics. 2014 Jan;133(1):e8-13. doi: 10.1542/peds.2013-1646. Epub 2013 Dec 16.

  PMID: 24344111 BACKGROUND

• Mandelberg A, Amirav I. Hypertonic saline or high volume normal saline for viral bronchiolitis: mechanisms and rationale. Pediatr Pulmonol. 2010 Jan;45(1):36-40. doi: 10.1002/ppul.21185. No abstract available.

  PMID: 20014350 BACKGROUND

• Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.

  PMID: 21073773 BACKGROUND

Related Links

• University Hospital of Sao Paulo University

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution, Hypertonic; X-Rays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Results Point of Contact

• Title: Dr. Mateus Deckers Leme
• Organization: Hospital Universitario - Sao Paulo University

mateusdl@gmail.com

X551130919200

Study Officials

• Mateus D Leme, MD

  Sao Paulo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 12, 2015
• Results First Posted: January 12, 2015

Record last verified: 2015-01

Locations

BR (1)