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

NCT ID: NCT06069336

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-04-30

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type: DRUG

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).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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 5 Weeks
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Szpital im. Św. Jadwigi Śląskiej

OTHER

Sponsor Role: lead

Responsible Party

Henryk Szymański

Head of Paediatric Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

Poland

References

Szupienko S, Buczek A, Szymanski H. Nebulised 3% hypertonic saline versus 0.9% saline for treating patients hospitalised with acute bronchiolitis: protocol for a randomised, double-blind, multicentre trial. BMJ Open. 2023 Nov 27;13(11):e080182. doi: 10.1136/bmjopen-2023-080182.

Reference Type: DERIVED

PMID: 38011984 (View on PubMed)

Other Identifiers

1/2023

Identifier Type: -

Identifier Source: org_study_id