NCT01238848

Brief Summary

The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4 months until next milestone

Results Posted

Study results publicly available

August 17, 2012

Completed
Last Updated

February 10, 2017

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

November 9, 2010

Results QC Date

July 16, 2012

Last Update Submit

December 20, 2016

Conditions

Bronchiolitis

Keywords

HypertonicSalineBronchiolitisEfficacy

Outcome Measures

Primary Outcomes (1)

  • Hospitalization Days

    hospitalization days

    Participants will be followed for the duration of hospitalization, an expected average of 4 days

Secondary Outcomes (1)

  • Length of Oxygen Use

    Participants will be followed for the duration of hospitalization, an expected average of 4 days

Study Arms (2)

Hypertonic

EXPERIMENTAL

Nebulized hypertonic saline (sodium chloride 3%) + albuterol

Drug: Hypertonic saline

Normal

ACTIVE COMPARATOR

Normal saline (sodium chloride 0.9%) + albuterol

Drug: Normal saline

Interventions

Hypertonic salineDRUG

3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Also known as: ClNa 3% (sodium chloride 3%)
Hypertonic
Normal salineDRUG

3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Also known as: ClNa 0.9% (sodium chloride 0.9%)
Normal

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

You may not qualify if:

  • Chronic respiratory or cardiovascular disease, respiratory failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Niños Pedro de Elizalde

Buenos Aires, Buenos Aires F.D., C1270AAN, Argentina

Location

Related Publications (3)

  • Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulized hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006458. doi: 10.1002/14651858.CD006458.pub2.

    PMID: 18843717BACKGROUND

  • Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.

    PMID: 20713480BACKGROUND

  • Zhang L, Mendoza-Sassi RA, Wainwright CE, Aregbesola A, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2023 Apr 4;4(4):CD006458. doi: 10.1002/14651858.CD006458.pub5.

    PMID: 37014057DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution, HypertonicSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsCrystalloid SolutionsIsotonic SolutionsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Limitations and Caveats

The initially estimated sample size was not achieved

Results Point of Contact

Title
Maria I. Espelt, MD
Organization
Hospital General de Niños Pedro de Elizalde
cespelt@fibertel.com.ar
541146136968

Study Officials

  • Maria I Espelt, MD

    Hospital General de Niños Pedro de Elizalde

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 11, 2010

Study Start

December 1, 2010

Primary Completion

October 1, 2011

Study Completion

May 1, 2012

Last Updated

February 10, 2017

Results First Posted

August 17, 2012

Record last verified: 2012-07

Locations

AR(1)