A Phase 4 interventional study of 3% hypertonic saline solution in Bronchiolitis, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 30 Days to 2 Years. Per ClinicalTrials.gov, last updated 2011-02-21.
Sponsored by Federico II University · Phase 4, Interventional, and Treatment
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.
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.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's enrollment of 136 is above the median of 80 across 249 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
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).
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).
time of hospitalization
length of stay
Time frame: six days
Clinical response before and 30 minutes after nebulisation by score
Time frame: 30 minutes
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Federico II University