Status:
COMPLETED
Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis
Lead Sponsor:
Szpital im. Św. Jadwigi Śląskiej
Conditions:
Bronchiolitis
Eligibility:
All Genders
5-24 years
Phase:
NA
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 secretion...
Eligibility Criteria
Inclusion
- 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:
- Nasal flaring;
- Grunting;
- Use of accessory muscles;
- Intercostal and/or subcostal chest wall retractions;
- Apnoe.
- Crackles and/or wheezing.
- Aged 5 weeks - 24 months old.
- A caregiver must provide written informed consent.
Exclusion
- Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation \< 85% on room air).
- History of prematurity (gestational age \<34 weeks).
- Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic).
- Immunodeficiency.
- Gastro-oesophageal reflux.
- Diagnosis or suspicion of asthma.
- Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment.
- Inhaling bronchodilators within 24 hours before enrolment.
- Inhaling steroids within 24 hours before enrolment.
- Systemic steroid therapy in the preceding 2 weeks.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06069336
Start Date
November 1 2023
End Date
April 30 2025
Last Update
May 18 2025
Active Locations (3)
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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