NCT01247064

Brief Summary

The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 19, 2014

Completed
Last Updated

August 19, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

November 15, 2010

Results QC Date

March 14, 2014

Last Update Submit

July 31, 2014

Conditions

Bronchiolitis, ViralSaline Solution, Hypertonic

Keywords

BronchiolitisHypertonic Saline

Outcome Measures

Primary Outcomes (1)

  • Respiratory Assessment Change Score (RACS)

    The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.

    Baseline and 1 hour

Secondary Outcomes (4)

  • Rate of Hospitalization

    1 day

  • Respiratory Rate Change

    Baseline and 1 hour

  • Oxygen Saturation Change

    Baseline and 1 hour

  • Parental Perception of Improvement of Breathing After Study Medication

    1 hour

Study Arms (2)

Nebulized 3% Saline

EXPERIMENTAL
Drug: Nebulized 3% saline

Nebulized 0.9% Normal Saline

PLACEBO COMPARATOR
Drug: Nebulized 0.9% Normal Saline

Interventions

Nebulized 3% salineDRUG

4 mL of nebulized 3% saline once

Also known as: 3% Hypertonic Saline Solution for Inhalation
Nebulized 3% Saline
Nebulized 0.9% Normal SalineDRUG

4 mL of 0.9% nebulized normal saline once

Also known as: 0.9% Saline Solution for Inhalation
Nebulized 0.9% Normal Saline

Eligibility Criteria

Age2 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 8 weeks through 23 months
  • First episode of wheezing associated with respiratory distress and upper respiratory tract infection.
  • Respiratory Distress Assessment Instrument (RDAI) rating of ≥4 and ≤15 after initial albuterol nebulization per standard care
  • Pediatric Emergency Medicine (PEM) physician does not plan additional bronchodilator therapy within the hour after initial assessment.
  • Parental/guardian permission (informed consent)

You may not qualify if:

  • Subjects with prior history of wheezing or asthma or who have received bronchodilator therapy prior to the current illness
  • Chronic lung or heart disease
  • Critically ill infants requiring immediate airway stabilization
  • Non-English speaking parent/guardian
  • Inability to take nebulized medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

  • Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196.

    PMID: 19884591BACKGROUND

  • 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

  • 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: 17719935BACKGROUND

  • Tal G, Cesar K, Oron A, Houri S, Ballin A, Mandelberg A. Hypertonic saline/epinephrine treatment in hospitalized infants with viral bronchiolitis reduces hospitalization stay: 2 years experience. Isr Med Assoc J. 2006 Mar;8(3):169-73.

    PMID: 16599051BACKGROUND

  • 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: 12576370BACKGROUND

  • Sarrell EM, Tal G, Witzling M, Someck E, Houri S, Cohen HA, Mandelberg A. Nebulized 3% hypertonic saline solution treatment in ambulatory children with viral bronchiolitis decreases symptoms. Chest. 2002 Dec;122(6):2015-20. doi: 10.1378/chest.122.6.2015.

    PMID: 12475841BACKGROUND

  • Florin TA, Shaw KN, Kittick M, Yakscoe S, Zorc JJ. Nebulized hypertonic saline for bronchiolitis in the emergency department: a randomized clinical trial. JAMA Pediatr. 2014 Jul;168(7):664-70. doi: 10.1001/jamapediatrics.2013.5306.

    PMID: 24862342DERIVED

MeSH Terms

Conditions

Bronchiolitis, ViralBronchiolitis

Interventions

Sodium ChlorideSaline Solution, HypertonicInhalationSaline Solution

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsVirus DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHypertonic SolutionsSolutionsPharmaceutical PreparationsRespiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaCrystalloid SolutionsIsotonic Solutions

Results Point of Contact

Title
Todd Florin
Organization
Cincinnati Children's Hospital Medical Center
todd.florin@cchmc.org
513-636-7966

Study Officials

  • Joseph Zorc, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Todd Florin, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 24, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 19, 2014

Results First Posted

August 19, 2014

Record last verified: 2014-07

Locations

US(1)