Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis

Viral Bronchiolitis Clinical Trial

Official title:

Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677729
• Other study ID #: HSERFLA
• Secondary ID: PAED-214-08
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2008
• Last updated: November 12, 2015
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay.

Hypothesis: When infants first present to the ER, frequent administration of HS over a brief time period will provide significant symptom improvement such that the need for hospital admission will be reduced.

Objective: To determine in a randomized, controlled and double-blind fashion if the short term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce the rate of hospital admission for infants presenting with moderately severe viral bronchiolitis.

Description:

Patients presenting to the Emergency Room (ER) or out-patient department with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. After the initial routine assessment by the ER medical and nursing staff, informed consent will be obtained and the infant will be randomized to receive treatment in a double-blinded fashion with 4 ml of nebulized study solution containing 1 mg salbutamol (bronchodilator) plus either 3% hypertonic saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 3 doses. After an observation period of 1 hour following the last dose, the infant will be reassessed by the attending physician in the ER for disposition (admit, discharge home, remain in ER for further treatment) at which point the infant's active involvement in the study will end. All subsequent therapy, if needed, will be at the sole discretion of the attending physician. The family of each recruited subject will be contacted by phone 7 days later to assess resolution of symptoms or the presence of any unexpected adverse effects.

Clinical response to the above treatment will also be determined independently by the study physician or designate utilizing a standardized respiratory scoring system, the Respiratory Distress Assessment Instrument (RDAI), at study entry and after the post-treatment observation period. The primary outcome measure is to compare the rate of admission to hospital between the study and control groups. A secondary outcome measure will involve the assessment of change in the RDAI between study entry and post-treatment.

The infant will remain in the ER throughout the study period and receive standard ongoing monitoring by the nursing staff. In the unlikely event of significant clinical worsening during this period, the ER physician on duty will be notified to assess and intervene as he/she feels appropriate. The site study investigator will be immediately notified of all such occurrences by the research assistant involved.

The study will be conducted over a single bronchiolitis season from November 1, 2008 to April 1, 2009. There will be 2 study sites as listed below with the name of the study site director.

• Royal Victoria Hospital of Barrie (Emergency Department), Barrie ON (B.A. Kuzik, MD, FRCP (lead investigator))

• Kingston General Hospital (Emergency Department) and Hotel Dieu Hospital (Emergency Department, Children's Outpatient Centre), Kingston ON (M. P. Flavin, MB, MRCP, FRCP)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

1. < 24 months.

2. presenting to ER or outpatient department with moderately severe viral bronchiolitis defined as:

1. history of viral upper respiratory tract infection within previous 7 days, plus

2. presence of wheezing and/or crackles on chest auscultation, plus

3. Respiratory Distress Assessment Instrument (RDAI, appendix B) score > 4 (of 17) or transcutaneous oxygen saturation (SaO2) < 94% in room air.

Patient exclusion criteria:

1. history of immunodeficiency or chronic cardiopulmonary disease (other than past history of wheezing).

2. critical illness at presentation.

3. use of nebulized HS within previous 12 hr.

4. prematurity (gestational age < 34 weeks).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral
• Viral Bronchiolitis

Intervention

Drug:
• solution contains 1 mg salbutamol plus 3% hypertonic saline
4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline every 20 minutes for a total of 3 doses
• solution contains 1 mg salbutamol plus 0.9% saline
4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) every 20 minutes for a total of 3 doses

Locations

Country	Name	City	State
Canada	The Royal Victoria Hospital	Barrie	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston	Kingston	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Queen's University	Kingston General Hospital, Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston, Royal Victoria Hospital Of Barrie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the rate of admission to hospital between the study and control groups		1 hour after treatment ends	No
Secondary	change in the RDAI between study entry and post-treatment.		1 hour after treatment ends	No