Nebulised 3% Hypertonic Saline Versus 0,9% Saline for Treating Patients Hospitalised With Acute Bronchiolitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Hypertonic saline 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. |
Drug: Hypertonic 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
|
| Placebo Comparator: Normal saline 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. |
Drug: Normal 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
|
Outcome Measures
Primary Outcome Measures
- Length of hospital stay (LOS). [From admission to hospital discharge]
Secondary Outcome Measures
- Number of participants requiring oxygen supplementation [During the intervention]
- 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
- Number of participants requiring hospital readmission after discharge [7 days after the end of interventions]
- Number of adverse events [7 days after the end of interventions]
especially incidence of acute otitis media and pneumonia
- Number of participants requiring PICU admission [7 days after the end of interventions]
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
Eligibility Criteria
Criteria
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:
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Tachypnoea (WHO definition).
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Increased respiratory effort manifested as follows:
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. Nasal flaring;
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Grunting;
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Use of accessory muscles;
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Intercostal and/or subcostal chest wall retractions;
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Apnoe.
- Crackles and/or wheezing.
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Aged 5 weeks - 24 months old.
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A caregiver must provide written informed consent.
Exclusion Criteria:
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Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation < 85% on room air).
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History of prematurity (gestational age <34 weeks).
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Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic).
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Immunodeficiency.
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Gastro-oesophageal reflux.
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Diagnosis or suspicion of asthma.
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Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment.
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Inhaling bronchodilators within 24 hours before enrolment.
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Inhaling steroids within 24 hours before enrolment.
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Systemic steroid therapy in the preceding 2 weeks.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Szpiatal im.Świętej Jadwigi Śląskiej | Trzebnica | Poland | 55-100 | |
| 2 | Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie | Warsaw | Poland | 02-091 | |
| 3 | Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu | Wałbrzych | Poland | 58-309 |
Sponsors and Collaborators
- Szpital im. Św. Jadwigi Śląskiej
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1/2023