Acute viral bronchiolitis (an infection of the lower airways) in infants under two years of age. This is usually caused by Respiratory Syncytial Virus (RSV). The diagnosis of viral bronchiolitis will be made clinically and infants must fulfil the following criteria: prolonged (wheezing) expiration, tachypnoe and dyspnoe, frequently leading to respiratory insufficienty.
Conditions
Interventions
Trade Name: Natriumchloride solution 5.85%
Product Name: Natriumchloride solution 5.85%
Product Code: RVG 55988
Pharmaceutical Form: Intravenous infusion
CAS Number: 7647-14-5
Other descriptive name:
Sponsors
VieCuri Medisch Centrum voor Noord-Limburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants younger than 24 months admitted with a viral bronchiolitis (prolonged and/or wheezing exspiration, tachypnoe and dyspnoe), a Wang-score of two or more and without a positive reaction on Salbutamol inhalation are included, after informed parental consent. 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
Exclusion criteria
Exclusion criteria: Exclusion criteria are: haemodynamically important congenital cardiac disease, chronic pre-existent respiratory disease, T-cell immunodeficienty and admission of the patient with a viral bronchiolitis not due to clinical reasons, for instance social problems. Infants who are treated with systemic corticosteroids will also be excluded from the study, as are infants suspected to have underlying asthma and/or allergy. This includes infants with eczema or food-allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this randomised, double-blind, placebo controlled study is to evaluate what effect different concentrations of hypertonic saline solution have on hospital stay in infants with viral bronchiolitis. The primary objective is the number of days of admission, including days after possible transfer to the Pediatric Intensive Care Unit (PICU) if there is need for mechanical ventilation. Infants are discharged from the study when they do not need supplemental oxygen, intravenous fluids or tube feeding during at least 12 hours. If the discharge criteria, as mentioned above, are reached, the study will be completed at that point. Even though the actual discharge from hospital can be postponed due to logistical or social reasons.;Secondary Objective: Secondary objectives are the necessity for transfer to a Pediatric Intensive Care Unit (PICU), the duration of supplemental oxygen treatment and the necessity for supportive treatment such as tube feeding, antibiotic treatment or bronchus dilatation. It will also be studied what sorts of viruses are responsible for bronchiolitis (RSV, Influenza, Parainfluenza or Rhinovirus) and whether infants with these different viruses react differently to inhalation of hypertonic saline solution. Potential differences can result in subgroup-analysis. ;Primary end point(s): The primary end point is the time to discharge, including duration of the treatment following a possible transfer to a paediatric intensive care unit. Discharge is defined as the time from which no additional oxygen therapy is required (oxygen saturation in rest in room air > 95%) and / or no need for intravenous fluids or gastric tube feeding for at least 12 hours. These criteria apply even in cases where actual discharge from hospital is delayed for logistical or social reasons. | — |
Countries
Netherlands
Outcome results
None listed