A Phase 3 interventional study of 3% Saline and 0.9% Normal Saline in Acute Viral Bronchiolitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 21 sites in France. Open to participants aged 6 Weeks to 12 Months. Per ClinicalTrials.gov, last updated 2014-07-28.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).
Acute viral bronchiolitis remains a significant cause of hospitalization and to date, no treatment reduce the rate of hospitalization. The only accepted treatment for bronchiolitis is nasal cleaning, hydration and for hospitalized hypoxemic infants, oxygen administration.
Several studies shown that nebulization of hypertonic saline solution reduce length of stay in hospital for hospitalized infant but effect on rate of hospitalization remains unclear.
The investigators propose a randomized double blind multicenter clinical trial on infants 6 weeks to 12 months old with moderate or severe bronchiolitis, in 21 emergency departments of hospitals situated France, during 2 winter seasons.
The investigators hypothesize that infants with bronchiolitis treated with nebulized hypertonic 3% saline solution would have less risk of being hospitalized. Our principal objective is to determine if nebulized 3% hypertonic saline solution reduces admission rate 24 hours after treatment compared to placebo.
Secondary objectives are to compare between groups intensity of respiratory symptoms measured by RDAI clinical score, duration of symptoms, length of hospital stay for hospitalized infants, adverse effects and health care utilization.
Patients presenting to the Emergency Department with a diagnosis of moderately severe bronchiolitis will be approached for entry into the study. After the initial routine assessment, informed consent will be obtained and the infant will be randomized to receive treatment in a double-blinded fashion 4 ml of nebulized study solution either 3% hypertonic saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 2 doses. After an observation period of 20 minutes following the last dose, the infant will be reassessed by the attending physician in the ER for disposition (admit, discharge home). All subsequent therapy, if needed, will be at the sole discretion of the attending physician. The family of each recruited subject will be contacted by phone 2, 7, 14 and 28 days later to assess resolution of symptoms.
Clinical response to the above treatment will also be determined independently by the study physician utilizing a standardized respiratory scoring system, the Respiratory Distress Assessment Instrument (RDAI), at study entry and after each nebulization. The primary outcome measure is the rate of admission to hospital between the study and control groups 24 hours after inclusion. Secondary outcomes measure will involve the assessment of change in the RDAI between study entry and post-treatment, adverse effects, length of stay for hospitalized infant and health care utilization.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 778 is above the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Compared within Bronchiolitis, Viral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bronchiolitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nebulized 3% Saline
Drug: 3% Saline
Nebulized 0.9% normal saline
Drug: 0.9% Normal Saline
Two 4 mL nebulization of 3% saline with 20 minutes interval
Also known as: 3% Hypertonic Saline Solution for Inhalation (Mucoclear 3%)
Two 4 mL nebulization of 0.9% normal saline with 20 minutes interval
Also known as: 0.9% Saline Solution for Inhalation
Admission rate
Time frame: 24 hours
change in RDAI score
Time frame: 2 hours
Number of Participants with Adverse Events
Time frame: 2 hours
length of hospitalization for hospitalized infant
Time frame: 1 month
health care utilisation
Time frame: 1 month
The record gives a start of Oct 2012, a primary completion of Apr 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Saline Solution
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