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

Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis: Protocol of a Randomized, Double-blind, Multicentre Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis
• Intervention / Treatment: Drug: Hypertonic saline; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henryk Szymański, MD; Phone Number: 0048604467073; Email: henryk.t.szymanski@gmail.com

Study Locations

• Poland
  • Trzebnica, Poland, 55-100
    • Recruiting
    • Szpiatal im.Świętej Jadwigi Śląskiej
    • Contact: Henryk Szymański, MD PhD; Phone Number: 0048604467073; Email: henryk.t.szymanski@gmail.com
    • Principal Investigator: Sara Szupieńko, MD
    • Principal Investigator: Aleksandra Buczek, MD
  • Warsaw, Poland, 02-091
    • Not yet recruiting
    • Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie
  • Wałbrzych, Poland, 58-309
    • Not yet recruiting
    • Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Placebo Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay (LOS).	From admission to hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants requiring oxygen supplementation		During the intervention
Number of participants requiring hospital readmission after discharge		7 days after the end of interventions
Number of adverse events	especially incidence of acute otitis media and pneumonia	7 days after the end of interventions
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
Duration of oxygen supplementation	among those requiring oxygen	During the intervention
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
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

Collaborators and Investigators

• Sponsor: Szpital im. Św. Jadwigi Śląskiej

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: infants; RCT; hypertonic saline
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 1/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or generated during this study will be made available after the publication of results
• IPD Sharing Time Frame: Avaliable after the publication
• IPD Sharing Access Criteria: Upon researcher's personal request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No