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Completed

NCT Number: NCT01488448

A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

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).

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Key information

Conditions

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

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

About this study

Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. There have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. Several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the United States and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the United States. The objective of this study is to conduct the first double-blind, randomized controlled trial in the United States of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

3% sodium chloride

Drug

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

Other names: hypertonic saline, HS

0.9% Sodium Chloride

Drug

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

Other names: normal saline, NS

Primary outcomes

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

    Time frame: Time of first study treatment until time of discharge

    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.

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

    Time frame: Time of first study treatment until time of discharge

    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.

Secondary outcomes

  1. Readmission for Bronchiolitis Within 7 Days of Discharge

    Time frame: within 7 days of hospital discharge

    Phone call at 7 days to assess for readmission to any hospital

  2. Clinical Worsening

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

    transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment

  3. Total Adverse Events

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

    Clinical worsening events (defined prior) + 7 day readmissions

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Dec 8, 2011
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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