Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis

Szpital im. Św. Jadwigi Śląskiej

Status: Completed

Conditions: Bronchiolitis

Treatments: Drug: Hypertonic saline; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06069336

1/2023

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 5 weeks to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Hypertonic saline

Active Comparator group

Description:

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.

Treatment:

Drug: Hypertonic saline

Normal saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline