Nebulized 5% Hypertonic Saline for the Treatment of Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Treatment 1. (5% Hypertonic saline + Epinephrine); Treatment 3. (3% Hypertonic saline + Epinephrine); Treatment 2. (Normal saline + Epinephrine)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nebulization of 4ml 5% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.; Nebulization of 4ml 3% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.; Nebulization of 4ml 0.9% saline mixed with 1.5 ml of epinephrine on enrollment and every 4 hours thereafter until ready for discharge.
Other intervention name(s): 5% Hypertonic saline; 3% Hypertonic saline; Normal saline
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiolitis, Viral; An acute inflammation of the upper RESPIRATORY TRACT