A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

NCT01488448 | Completed Results DMC

• 1 other identifier: 11-09-329
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).

Conditions

Bronchiolitis

Keywords

Hypertonic saline; Bronchiolitis; Infants; Wheezing; Nebulized; Bronchodilator

Outcome Measures

Primary Outcomes (2)

• Length of Stay in the Study-LOS--Intention to Treat Analysis

  Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.

  Time of first study treatment until time of discharge

• Length of Stay in the Study-LOS by Per Protocol Analysis

  Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.

  Time of first study treatment until time of discharge

Secondary Outcomes (3)

• Readmission for Bronchiolitis Within 7 Days of Discharge

  within 7 days of hospital discharge

• Clinical Worsening

  though hospitalization/time period receiving study treatment, average 2-3 days

• Total Adverse Events

  Time of enrollment in the study through 1 week after hospital discharge

Study Arms (2)

Nebulized Hypertonic Saline

EXPERIMENTAL

4mL nebulized 3% sodium chloride every 4 hours until discharge

Drug: 3% sodium chloride

Nebulized Normal Saline

PLACEBO COMPARATOR

4 mL nebulized 0.9% sodium chloride every 4 hours until discharge

Drug: 0.9% sodium chloride

Interventions

3% sodium chloride DRUG

4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Also known as: hypertonic saline, HS

Nebulized Hypertonic Saline

0.9% sodium chloride DRUG

4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Also known as: normal saline, NS

Nebulized Normal Saline

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis.

You may not qualify if:

• status asthmaticus
• chronic cardiopulmonary disease
• Trisomy 21
• immunodeficiency or transplant recipient
• neuromuscular disease
• admission directly to the intensive care unit
• previous use of nebulized hypertonic saline less than 12 hours prior to presentation
• previous enrollment in the study in the 72 hours prior to presentation

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Silver AH, Esteban-Cruciani N, Azzarone G, Douglas LC, Lee DS, Liewehr S, Nazif JM, Agalliu I, Villegas S, Rhim HJ, Rinke ML, O'Connor K. 3% Hypertonic Saline Versus Normal Saline in Inpatient Bronchiolitis: A Randomized Controlled Trial. Pediatrics. 2015 Dec;136(6):1036-43. doi: 10.1542/peds.2015-1037. Epub 2015 Nov 9.

  PMID: 26553190 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Respiratory Sounds

Interventions

Sodium Chloride; Saline Solution, Hypertonic; Saline Solution

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Results Point of Contact

• Title: Dr. Alyssa Silver
• Organization: Children's Hospital at Montefiore/Albert Einstein College of Medicine

alysilve@montefiore.org

718-741-2304

Study Officials

• Alyssa H Silver, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: Attending Physician, Pediatric Hospitalist, Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 8, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2015
• Last Updated: February 2, 2017
• Results First Posted: August 22, 2014

Record last verified: 2017-01

Locations

US (1)