Clinical trial NCT06069336: Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis
Official title: Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis: Protocol of a Randomized, Double-blind, Multicentre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: hypertonic saline
infants
RCT
Lead sponsor: Szpital im. Św. Jadwigi Śląskiej
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 180
Sex: ALL
Minimum age (years): 5
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will occur within 24 hours of admission
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Length of hospital stay (LOS).
timeFrame: From admission to hospital discharge
Secondary outcomes:
measure: Number of participants requiring oxygen supplementation
timeFrame: During the intervention
measure: Duration of oxygen supplementation
timeFrame: During the intervention
measure: The time until the infant will be assessed as being 'fit for discharge'
timeFrame: During the intervention
measure: Number of participants requiring hospital readmission after discharge
timeFrame: 7 days after the end of interventions
measure: Number of adverse events
timeFrame: 7 days after the end of interventions
measure: Worsening of clinical status, including the following:
timeFrame: During the intervention
measure: Value of clinical severity score (RDAI and Wang Scale)
timeFrame: During the intervention
Other outcomes:
Locations:
city: Trzebnica
country: Poland
facility: Szpiatal im.Świętej Jadwigi Śląskiej
city: Warsaw
country: Poland
facility: Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie
city: Wałbrzych
country: Poland
facility: Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu
Study officials:
References: