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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01300325
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : February 21, 2011
Sponsor:
Information provided by:
Federico II University

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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Other: 3% hypertonic saline solution Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Nebulized Hypertonic Saline and Epinephrine in Hospitalized Infants With Bronchiolitis
Study Start Date : November 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : December 2010


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).



Primary Outcome Measures :
  1. time of hospitalization [ Time Frame: six days ]
    length of stay


Secondary Outcome Measures :
  1. Clinical response before and 30 minutes after nebulisation by score [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300325


Locations
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Italy
Azienda Sanitaria Locale Napoli 2 Nord
Pozzuoli, Napoli, Italy, 80072
Sponsors and Collaborators
Federico II University
Investigators
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Study Director: Michele Miraglia, MD Pediatric Department

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Responsible Party: Michele Miraglia, Dipartimento di Pediatria
ClinicalTrials.gov Identifier: NCT01300325    
Other Study ID Numbers: ENHS
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: January 2011
Keywords provided by Federico II University:
Bronchiolitis, 3% Hypertonic Saline Solution
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Epinephrine
Racepinephrine
Pharmaceutical Solutions
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents