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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic saline | Active Comparator | 3% hypertonic saline (NEBU-dose hypertonic). The treatment will be delivered through nebulisation using oxygen with 5 litres of O2 flow, or through a compressed air-driven jet nebuliser, every 6 hours for three times daily with a night break, until discharge. |
|
| Normal saline | Placebo Comparator | 0,9% normal saline (NEBU-dose isotonic).The treatment will be delivered through nebulisation using oxygen with 5 litres of O2 flow, or through a compressed air-driven jet nebuliser, every 6 hours for three times daily with a night break, until discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline | Drug | Nebulised 3% hypertonic saline (NEBU-dose hypertonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay (LOS). | From admission to hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants requiring oxygen supplementation | During the intervention | |
| Duration of oxygen supplementation | among those requiring oxygen | During the intervention |
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Inclusion Criteria:
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:
Crackles and/or wheezing.
Aged 5 weeks - 24 months old.
A caregiver must provide written informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szpiatal im.Świętej Jadwigi Śląskiej | Trzebnica | 55-100 | Poland | |||
| Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38011984 | Derived | Szupienko S, Buczek A, Szymanski H. Nebulised 3% hypertonic saline versus 0.9% saline for treating patients hospitalised with acute bronchiolitis: protocol for a randomised, double-blind, multicentre trial. BMJ Open. 2023 Nov 27;13(11):e080182. doi: 10.1136/bmjopen-2023-080182. |
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The datasets used and/or generated during this study will be made available after the publication of results
Avaliable after the publication
Upon researcher's personal request
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000077324 | Crystalloid Solutions |
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Randomization will occur within 24 hours of admission
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| Normal saline | Drug | 0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse |
|
| 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 | During the intervention |
| Number of participants requiring hospital readmission after discharge | 7 days after the end of interventions |
| Number of adverse events | especially incidence of acute otitis media and pneumonia | 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. | 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 | During the intervention |
| Warsaw |
| 02-091 |
| Poland |
| Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu | Wałbrzych | 58-309 | Poland |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D007552 |
| Isotonic Solutions |