Bronchiolitis
Conditions
Keywords
hypertonic saline, infants, RCT
Brief summary
Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus (RSV). Only supportive therapy, including suctioning nasal secretions, water-electrolyte balance maintenance, and oxygen supplementation when needed, is recommended. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty. The aim of the study is to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.
Interventions
DRUGHypertonic saline
Nebulised 3% hypertonic saline (NEBU-dose hypertonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse
DRUGNormal saline
0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse
Sponsors
Szpital im. Św. Jadwigi Śląskiej
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomization will occur within 24 hours of admission
Eligibility
Sex/Gender
ALL
Age
5 Weeks to 24 Months
Healthy volunteers
No
Inclusion criteria
1. Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms: * Tachypnoea (WHO definition). * Increased respiratory effort manifested as follows: 1. Nasal flaring; 2. Grunting; 3. Use of accessory muscles; 4. Intercostal and/or subcostal chest wall retractions; 5. Apnoe. * Crackles and/or wheezing. 2. Aged 5 weeks - 24 months old. 3. A caregiver must provide written informed consent.
Exclusion criteria
1. Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation \< 85% on room air). 2. History of prematurity (gestational age \<34 weeks). 3. Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic). 4. Immunodeficiency. 5. Gastro-oesophageal reflux. 6. Diagnosis or suspicion of asthma. 7. Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment. 8. Inhaling bronchodilators within 24 hours before enrolment. 9. Inhaling steroids within 24 hours before enrolment. 10. Systemic steroid therapy in the preceding 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay (LOS). | From admission to hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of oxygen supplementation | During the intervention | among those requiring oxygen |
| The time until the infant will be assessed as being 'fit for discharge' | During the intervention | which is defined as the point at which the infant will be feeding adequately (taking \>75% of their usual intake based on parents' assessment) and will have a saturation of at least 92% for 6 h on room air, while the axillary body temperature will remain - among those requiring oxygen |
| Number of participants requiring hospital readmission after discharge | 7 days after the end of interventions | — |
| Number of participants requiring oxygen supplementation | During the intervention | — |
| Worsening of clinical status, including the following: | During the intervention | PICU admission The need for oxygen supplementation via HNFC; Bronchospasm within 30 minutes of a nebulised study treatment as indicated by an increase/worsening of the RDAI of \<4 points. |
| Value of clinical severity score (RDAI and Wang Scale) | During the intervention | 30 minutes after intervention and 24 h, 48 h, and 72 h after enrolment |
| Number of adverse events | 7 days after the end of interventions | especially incidence of acute otitis media and pneumonia |
Countries
Poland
Outcome results
None listed