Does nebulised hypertonic (3%) saline reduce the duration of hospital admission in infants with bronchiolitis?

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Categorie Primary study
Registry of TrialsEU Clinical Trials Register
Year 2010
INTERVENTION: Product Name: Hypertonic saline (3%) Pharmaceutical Form: Nebuliser solution INN or Proposed INN: 3% (hypertonic) saline (NaCl) Concentration unit: % percent Concentration type: equal Concentration number: 3‐ Trade Name: Ventolin (Salbutamol) Product Name: Ventolin (Salbutamol) Product Code: PL 10949/0244 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Salbutamol CAS Number: 18559‐94‐9 Other descriptive name: Ventolin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ CONDITION: Viral bronchiolitis (in infants aged under 1yr old) ; MedDRA version: 12‐1 Level: LLT Classification code 10038718 Term: (Respiratory syncytial virus) bronchiolitis PRIMARY OUTCOME: Main Objective: To determine whether using nebulised 3% saline (salty water) is effective in reducing the severity and duration of symptoms in bronchiolitis, which is a viral respiratory infection affecting children under the age of 12 months.; ; The outcomes that will be measured are a) duration of hospital stay and b) duration of supplemental oxygen requirement. Primary end point(s): Duration of hospital stay; Secondary Objective: None INCLUSION CRITERIA: Inclusion criteria ‐ all infants under the age of 12 months with a clinical diagnosis of bronchiolitis Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: dc4ca09089f30c749229d5e3cb81c96f1df7fa0d
First added on: Aug 22, 2024