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Effect of inhaled hypertonic saline solution to treat infants hospitalizid with viral bronchiolitis.

Conditions
viral bronchiolitishypertonic saline solutioninfantshypertoon zoutzuigelingenRSV
Registration Number
NL-OMON27764
Lead Sponsor
none
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
161
Inclusion Criteria

1. 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.

Exclusion Criteria

1. Haemodynamically important congenital cardiac disease.

2. 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
- 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.
Secondary Outcome Measures
NameTimeMethod
- The secondary study parameters include the need for transfer to a pediatric intensive care unit (PICU) if there is the need of mechanical ventilation, the length of supplemental oxygen requirement, and the need for additional support measure such as enteral feeding, antibiotics or bronchus dilator therapy.<br /><br>The following parameters will be registered: <br /><br>- positive immunoflourescent test for RSV, <br /><br>- influenza,<br /> <br>- para-influenza or rhino- virus,<br /><br>- wang score before and after therapy.
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