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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Nebulised 3% hypertonic saline (NEBU-dose hypertonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse
0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse
Szpiatal im.Świętej Jadwigi Śląskiej
Trzebnica, Poland
Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie
Warsaw, Poland
Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych, Poland
Length of hospital stay (LOS).
Time frame: From admission to hospital discharge
Number of participants requiring oxygen supplementation
Time frame: During the intervention
Duration of oxygen supplementation
among those requiring oxygen
Time frame: During the intervention
The time until the infant will be assessed as being 'fit for discharge'
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
Time frame: During the intervention
Number of participants requiring hospital readmission after discharge
Time frame: 7 days after the end of interventions
Number of adverse events
especially incidence of acute otitis media and pneumonia
Time frame: 7 days after the end of interventions
Worsening of clinical status, including the following:
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.
Time frame: During the intervention
Value of clinical severity score (RDAI and Wang Scale)
30 minutes after intervention and 24 h, 48 h, and 72 h after enrolment
Time frame: During the intervention
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