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OpenTrials
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NCT Number: NCT01300325

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.

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Key information

Conditions

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

Age range

30 day–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Azienda Sanitaria Locale Napoli 2 Nord

Pozzuoli, Napoli, 80072, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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%

Treatment and study plan

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).

Primary outcomes

  1. time of hospitalization

    Time frame: six days

    length of stay

Secondary outcomes

  1. Clinical response before and 30 minutes after nebulisation by score

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 21, 2011
Registry last updated
Feb 21, 2011

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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