NCT00619918

Brief Summary

This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
447

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2008

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

February 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 10, 2013

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

3.2 years

First QC Date

February 8, 2008

Results QC Date

July 29, 2013

Last Update Submit

November 1, 2024

Conditions

Bronchiolitis

Keywords

bronchiolitishypertonic saline

Outcome Measures

Primary Outcomes (3)

  • Admission Rate

    Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.

    1 day

  • Length of Stay

    Length of stay defined as date of discharge minus date of admission (whole days)

    1 month

  • Change in RDAI Score

    The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement.

    1 Hour

Secondary Outcomes (3)

  • Hours of Oxygen Use

    14 days

  • IV Fluid Use

    14 days

  • Number of Participants With Supplemental Medication Use

    14 days

Study Arms (2)

Nebulized 3% Saline

EXPERIMENTAL

3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.

Drug: Nebulized 3% saline

Nebulized 0.9% Saline

PLACEBO COMPARATOR

0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.

Drug: Nebulized 0.9% saline

Interventions

Nebulized 3% salineDRUG

4 ml inhaled q8h

Also known as: 3% saline, Hypertonic saline, NaCl 3%
Nebulized 3% Saline
Nebulized 0.9% salineDRUG

normal saline

Also known as: Normal saline, NS, NaCl 0.9%
Nebulized 0.9% Saline

Eligibility Criteria

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

You may qualify if:

  • clinical diagnosis of viral bronchiolitis
  • between November and April

You may not qualify if:

  • prematurity \< 34 weeks
  • chronic lung disease
  • congenital heart disease
  • history of wheezing, asthma or albuterol use
  • tracheostomy status
  • need for intensive care of assisted ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital & Research Center at Oakland

Oakland, California, 94609, United States

Location

Related Publications (1)

  • Wu S, Baker C, Lang ME, Schrager SM, Liley FF, Papa C, Mira V, Balkian A, Mason WH. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial. JAMA Pediatr. 2014 Jul;168(7):657-63. doi: 10.1001/jamapediatrics.2014.301.

    PMID: 24862623DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Sodium ChlorideSaline Solution, HypertonicSaline Solution

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHypertonic SolutionsSolutionsPharmaceutical PreparationsCrystalloid SolutionsIsotonic Solutions

Limitations and Caveats

* Albuterol administered before each study treatment * Did not reach subject accrual goals * Number of patients recruited from inpatient unit too small to analyze separately

Results Point of Contact

Title
Susan Wu
Organization
Children's Hospital Los Angeles
suwu@chla.usc.edu
323-361-6177

Study Officials

  • Susan Wu, MD

    Childrens Hospital Los Angeles/University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
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
Assistant Professor of Clinical Pediatrics

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 21, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 5, 2024

Results First Posted

October 10, 2013

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)