Effectiveness of Nebulized Hypertonic Saline and Epinephrine in Hospitalized Infants With Bronchiolitis

Acute bronchiolitis is the main cause for respiratory illness that requires hospitalization in children younger than 2 years. In the United States it has been shown that the burden of the disease is considerable, having an annual cost of more than $ 500 million and being responsible for the 17% of all infant hospitalizations . Aim of the present study was to verify the effects of nebulized 3% saline solution in comparison to normal saline in addiction to epinephrine in a large population of RSV positive cases of bronchiolitis; all patients presented a disease as much as severe to require hospitalization.The main study endpoints were the length of stay in hospital and the clinical response.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: 3% hypertonic saline solution

Detailed Description

Among 136 patients assessed within 12 hours for entry into the study, 109 (69 males) accepted to participate, gave an informed consent and were randomly assigned either to receive every 6 hours the nebulized 0.9% saline (NS) (group I) or the 3% HS (group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids). Patients were randomized to receive different saline treatments using a computer-based randomization program. Study solutions, prepared by the local hospital pharmacy, were blinded to participants and investigators. Each treatment was delivered by a nebulizer with continuous flow of oxygen at 6 L/min through a tight-fitting facemask.

The main study endpoints were the length of stay (LOS) in hospital and the clinical response. LOS in hospital was defined as the time between study entry (within 12 hours of admission to the hospital) and the time at which the infant was discharged on the basis of the clinical grounds by the attending physician. Clinical response was determined using daily CSS evaluation; furthermore, the CSS was evaluated every day before and 30 minutes after nebulisation.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Napoli
    • Pozzuoli, Napoli, Italy, 80072
      • Azienda Sanitaria Locale Napoli 2 Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children aged less than 2 years old
• clinical diagnosis of bronchiolitis

Exclusion Criteria:

• cardiac or pulmonary diseases
• premature birth < 36 weeks of gestational age
• previous diagnosis of asthma
• an initial oxygen saturation of 85%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0.9% saline; patients receive every 6 hours the nebulized 0.9% saline (placebo comparator) (group I) or the 3% HS (group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).	Other: 3% hypertonic saline solution; Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).
No Intervention: 3% hypertonic saline; Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of hospitalization	length of stay	six days

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical response before and 30 minutes after nebulisation by score	30 minutes

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Study Director: Michele Miraglia, MD, Pediatric department

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (Estimate): February 21, 2011

Study Record Updates

• Last Update Posted (Estimate): February 21, 2011
• Last Update Submitted That Met QC Criteria: February 18, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Bronchiolitis, 3% Hypertonic Saline Solution
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: ENHS