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

Bronchiolitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069336
• Other study ID #: 1/2023
• Status: Recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: Szpital im. Sw. Jadwigi Slaskiej
• Contact: Henryk Szymanski, MD
• Phone: 0048604467073
• Email: henryk.t.szymanski[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Weeks to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	Szpiatal im.Swietej Jadwigi Slaskiej	Trzebnica
Poland	Specjalistyczny Szpital im. Alfreda Sokolowskiego w Walbrzychu	Walbrzych
Poland	Dzieciecy Szpital Kliniczny im. Polikarpa Brudzinskiego w Warszawie	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Szpital im. Sw. Jadwigi Slaskiej

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay (LOS).		From admission to hospital discharge
Secondary	Number of participants requiring oxygen supplementation		During the intervention
Secondary	Duration of oxygen supplementation	among those requiring oxygen	During the intervention
Secondary	The time until the infant will be assessed as being 'fit for discharge'	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	During the intervention
Secondary	Number of participants requiring hospital readmission after discharge		7 days after the end of interventions
Secondary	Number of adverse events	especially incidence of acute otitis media and pneumonia	7 days after the end of interventions
Secondary	Worsening of clinical status, including the following:	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.	During the intervention
Secondary	Value of clinical severity score (RDAI and Wang Scale)	30 minutes after intervention and 24 h, 48 h, and 72 h after enrolment	During the intervention