NCT00677729

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

May 2, 2008

Last Update Submit

November 12, 2015

Conditions

Viral Bronchiolitis

Keywords

bronchiolitishypertonic salineinfants

Outcome Measures

Primary Outcomes (1)

  • compare the rate of admission to hospital between the study and control groups

    1 hour after treatment ends

Secondary Outcomes (1)

  • change in the RDAI between study entry and post-treatment.

    1 hour after treatment ends

Study Arms (2)

1

ACTIVE COMPARATOR

4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline (NaCl)

Drug: solution contains 1 mg salbutamol plus 3% hypertonic saline

2

PLACEBO COMPARATOR

4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl)

Drug: solution contains 1 mg salbutamol plus 0.9% saline

Interventions

solution contains 1 mg salbutamol plus 3% hypertonic salineDRUG

4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline every 20 minutes for a total of 3 doses

1
solution contains 1 mg salbutamol plus 0.9% salineDRUG

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

2

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \< 24 months.
  • presenting to ER or outpatient department with moderately severe viral bronchiolitis defined as:
  • history of viral upper respiratory tract infection within previous 7 days, plus
  • presence of wheezing and/or crackles on chest auscultation, plus
  • Respiratory Distress Assessment Instrument (RDAI, appendix B) score \> 4 (of 17) or transcutaneous oxygen saturation (SaO2) \< 94% in room air.

You may not qualify if:

  • history of immunodeficiency or chronic cardiopulmonary disease (other than past history of wheezing).
  • critical illness at presentation.
  • use of nebulized HS within previous 12 hr.
  • prematurity (gestational age \< 34 weeks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston

Kingston, Ontario, Canada

Location

Related Publications (1)

  • 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: 21073773DERIVED

MeSH Terms

Conditions

Bronchiolitis, ViralBronchiolitis

Interventions

AlbuterolSaline Solution, HypertonicSodium Chloride

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsVirus DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesHypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Brian Kuzik, MD

    The Royal Victoria Hospital of Barrie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 14, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

CA(3)