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

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Drug: Normal saline; Drug: Hypertonic saline

• Registration Number: NCT06069336
• Lead Sponsor: Szpital im. Św. Jadwigi Śląskiej

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-23
• Study First Submitted QC: 2023-09-29
• Study First Posted: 2023-10-05
• Study Start: 2023-11-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	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.
Hypertonic saline	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.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay (LOS).	From admission to hospital discharge

Secondary Outcome Measures

Name	Time	Method
Number of participants requiring oxygen supplementation	During the intervention
Duration of oxygen supplementation	During the intervention	among those requiring oxygen
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 - among those requiring oxygen
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
Worsening of clinical status, including the following:	During the intervention	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.
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

Trial Locations

Locations (3)

Szpiatal im.Świętej Jadwigi Śląskiej; 🇵🇱 Trzebnica, Poland

Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie; 🇵🇱 Warsaw, Poland

Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu; 🇵🇱 Wałbrzych, Poland