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

NCT01300325 | Completed Phase 4 DMC

• 1 other identifier: ENHS
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis, 3% Hypertonic Saline Solution

Outcome Measures

Primary Outcomes (1)

• time of hospitalization

  length of stay

  six days

Secondary Outcomes (1)

• Clinical response before and 30 minutes after nebulisation by score

  30 minutes

Study Arms (2)

0.9% saline

PLACEBO COMPARATOR

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

3% hypertonic saline

NO INTERVENTION

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).

Interventions

3% hypertonic saline solution OTHER

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).

0.9% saline

Eligibility Criteria

• Age: 30 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Azienda Sanitaria Locale Napoli 2 Nord

Pozzuoli, Napoli, 80072, Italy

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Michele Miraglia, MD

  Pediatric Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 21, 2011
• Study Start: November 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 21, 2011

Record last verified: 2011-01

Locations

IT (1)