Please select the eligibility criteria that correspond to the clinical trial below.
Title: Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation
Brief Summary: Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the lungs, and then the airways become blocked, leading to difficulties with breathing. It is the most common reason why children are admitted to hospital, with 1-3% of all children admitted to hospital during their first winter, creating enormous strains on NHS services. The majority of those admitted with the condition are under six months of age and the associated stress for parents is considerable. After forty years of research the best treatment we have is supportive care and oxygen.

Recent research suggests that salt water, sprayed as a mist so that the children can breathe it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis. Scientists think that the salt water changes the mucus which blocks the airways so that it can be cleared more easily. Three small research studies all suggested that a child's time in hospital could be reduced by a quarter by using this treatment. If this was true, it would be good for children, their families and the children's wards trying to cope with the large numbers admitted with bronchiolitis every year.

To decide whether this treatment should be used throughout the NHS, we need to run a randomised controlled trial of hypertonic saline in a large number of children. The trial will tell us if adding saline to usual care reduces distress in both children and parents, as well as whether it reduces the length of time they stay in hospital. We will then know if the treatment is the best thing for children with bronchiolitis and whether it provides the NHS with good value for money.


Options:
A: Inclusion Criteria:

* Previously healthy infants under 1 year of age
* Admitted to hospital with a clinical diagnosis of acute bronchiolitis, following the UK definition of an infant with an apparent viral respiratory tract infection associated with airways obstruction manifest by hyperinflation, tachypnoea and subcostal recession with widespread crepitations on auscultation
* Requiring supplemental oxygen therapy on admission

Exclusion Criteria:

* Wheezy bronchitis or asthma - children with an apparent viral respiratory infection and wheeze with no or occasional crepitations
* Previous lower respiratory tract infections
* Risk factors for severe disease \[gestation \<32 weeks, immunodeficiency, neurological and cardiac conditions, chronic lung disease\]
* Subjects where the carer's English is not fluent and translational services are not available
* Requiring admission to high dependency or intensive care units at the time of recruitment
B: Inclusion Criteria:

* Patients age 6 weeks to ≤ 18 months
* Diagnosed with bronchiolitis (defined as viral respiratory illness and first episode of wheeze)
* BSS score of ≥ 4

Exclusion Criteria:

* A previous history of wheezing;
* diagnosis of asthma;
* any use of bronchodilators within 2 h of presentation
* gestational age ≤ 34 weeks
* history of congenital heart disease
* chronic pulmonary or chronic renal disease
* oxygen saturation of ≤ 85% at the time of recruitment
* severe disease requiring intensive care unit admission
* inability to obtain informed consent
C: Inclusion Criteria:

* Age 6 weeks to 24 Months.
* First episode of wheezing
* Fever, cough and watery nasal discharge

Exclusion Criteria :

* Any underlying cardiovascular disease.
* Prior wheezing.
* Clinical Severity Score \> 9.
* Atopic dermatitis, allergic rhinitis or asthma.
* Oxygen saturation (SpO2) \<85% on room air.
* Obtunded consciousness.
* Previous treatment with bronchodilators within 4 hours.
* Any steroid therapy within 48 Hours.
D: Inclusion Criteria:

* children between ages 6 weeks to 24 months
* first episode of wheezing
* diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score

Exclusion Criteria:

* Children with mild bronchiolitis (Wang score \< 5)
* Children with pre-existent cardiac disease
* Children with clinically significant chronic respiratory disease
* Immunocompromised children
* Children with a gestational age at birth less than 34 weeks
* Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy)
* Children who received corticosteroid in any form in the preceding 2 weeks before presentation
* Children who received bronchodilators within 24 hours before presentation
* Children with critical illness at presentation requiring immediate admission to intensive care unit

Answer: A