Track topics on Twitter Track topics that are important to you
The investigators reasoned that a hypertonic saline concentration higher than 3% could be safe and more efficacious in the treatment of bronchiolitis, alleviating severe symptoms and preventing the need for hospitalization in some instances.
We conducted a double blind, randomized, parallel-group clinical trial to compare the efficacy and safety of hypertonic saline 3% and 5% versus normal saline for the treatment of acute bronchiolitis.
The study was conducted in the short stay unit of the Pediatric Emergency Center of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. The Center serves an average of 200,000 patients annually and manages 42 beds in the short stay unit. Patients admitted to the unit were assessed at least every 6 hours by a pediatrician to determine readiness for discharge. The length of stay in the unit for bronchiolitis range from 6 to 168 hours.
Infants aged ≤18 months presenting to the unit for the treatment of moderate-severe viral bronchiolitis were eligible for the study. Moderate-severe bronchiolitis required having a prodromal history consistent with viral upper respiratory tract infection followed by wheezing and/or crackles on auscultation and a Wang bronchiolitis severity score of ≥ 4 on presentation.
Patients were excluded from the study if they had one or more of the following characteristics: Born preterm ≤34 weeks gestation, previous history of wheezing, steroid use within 48 hours of presentation, obtundation and progressive respiratory failure requiring ICU admission, history of apnea with in 24 hours before presentation, oxygen saturation ≤ 85% on room air at the time of recruitment, history of a diagnosis of chronic lung disease, congenital heart disease, or immunodeficiency.
The six attending physicians who covered the 18 beds in the respiratory section of the short stay unit were trained in scoring and its practical application on our bronchiolitis patients in the unit before the study began.
Written and informed consent, was sought from one of the parents or legal guardians for eligible patients as soon as the patient was admitted to the unit. The study was approved by the hospital institutional review board.
Patients were examined on presentation and those requiring further treatment or observation were admitted to the short stay unit. Those with bronchiolitis were assessed for study eligibility within 2 hours of the initial physician assessment. Patients for whom consent was obtained underwent plain chest radiography and nasopharyngeal swabs were taken for RSV detection (RSV Respi-Strip, Coris Bioconcept, Gembloux, Belgium). Then a computer-generated list of random numbers was used by the enrolling physicians in consecutive order to identify a sealed envelope containing one of three codes identifying one of three different bags of 500 mL of sterilely-prepared blinded study solution, made fresh each morning by a pharmacist blinded to patient assignment.Patients received the study nebulization mixed with 1.5 ml of epinephrine in a double blinded fashion on enrollment and every 4 hours thereafter until they were ready for discharge.Additional nebulized epinephrine 5ml delivered the same way was administered with blinded study solution at a maximum frequency of every hour and additional treatment (e.g., supplementary oxygen, hydration) given at the discretion of the treating physician. Patients were withdrawn from the study if oxygen saturation within 30 min after nebulization fell below 85% on room air or clinical deterioration was determined to warrant transfer to the pediatric intensive care unit. Patients were discharged when the treating physician determined the patient did not need supplementary oxygen, was feeding adequately without intravenous fluids, and had minimal or absent wheezing, crackles, and chest retractions provided he/she had an oxygen saturation ≥ 94% and severity score < 4 on discharge.
At discharge, patients were sent home with albuterol metered-dose inhalers . Follow-up by study nurse by telephone was mandatory daily, for one week after discharge. The patient could return to the pediatric emergency center earlier if desired or needed.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Treatment 1. (5% Hypertonic saline + Epinephrine), Treatment 3. (3% Hypertonic saline + Epinephrine), Treatment 2. (Normal saline + Epinephrine)
Pediatric Emergency Center, Al-Saad
Hamad Medical Corporation
Published on BioPortfolio: 2014-07-23T21:11:46-0400
Bronchiolitis is one of the main reasons for consultation in primary care and emergency services, as well as the leading cause of hospitalization for lower respiratory tract infection in c...
Hypertonic saline is used to treat elevated intracranial pressure. Intraosseous vascular access has been used to administer fluids and medications. This study combines these to administer ...
The study goal is to compare the management of increased intra-cranial pressure (ICP) using 3% hypertonic saline vs. mannitol (given in same osmolar loads). Primary hypothesis: 1. ...
A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale scores afte...
The study is designed to evaluate the efficacy and safety of intravenous infusion of hypertonic saline in BPH patients, candidates for TURP surgery using the monopolar electric resectoscop...
This study evaluated the cost-effectiveness of hypertonic saline (HS) inhalations for infant bronchiolitis, compared to normal saline inhalations or standard treatment without inhalations as controls.
Hemorrhagic shock-induced lung edema and inflammation are two of the main reasons for the rejection of lungs donated for transplantation. Hypertonic saline (HS) induces intravascular volume expansion ...
Saline nasal irrigation is labelled as an add-on treatment in patients with allergic rhinitis (AR). The primary aim of this study was to compare the efficacy of 21-day use of buffered hypertonic salin...
Uysalol M, Haşlak F, Özünal ZG, Vehid H, Uzel N. Rational drug use for acute bronchiolitis in emergency care. Turk J Pediatr 2017; 59: 155-161. Despite the large variety of inhaled treatment option...
To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponat...
Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).
A racemic mixture of d-epinephrine and l-epinephrine.
Product of epinephrine O-methylation. It is a commonly occurring, pharmacologically and physiologically inactive metabolite of epinephrine.
A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.
A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs. They're usually caused by viruses, but they can also ...