Back to resultsNebulised 3% Hypertonic Saline Versus 0,9% Saline for Treating Patients Hospitalised With Acute Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Hypertonic saline
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring hypertonic saline, infants, RCT
Eligibility Criteria
Inclusion Criteria: 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: . Nasal flaring; Grunting; Use of accessory muscles; Intercostal and/or subcostal chest wall retractions; Apnoe. Crackles and/or wheezing. Aged 5 weeks - 24 months old. A caregiver must provide written informed consent. Exclusion Criteria: Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation < 85% on room air). History of prematurity (gestational age <34 weeks). Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic). Immunodeficiency. Gastro-oesophageal reflux. Diagnosis or suspicion of asthma. Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment. Inhaling bronchodilators within 24 hours before enrolment. Inhaling steroids within 24 hours before enrolment. Systemic steroid therapy in the preceding 2 weeks.
Sites / Locations
- Szpiatal im.Świętej Jadwigi Śląskiej
- Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie
- Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Hypertonic saline
Normal saline
Arm 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.
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.
Outcomes
Primary Outcome Measures
Length of hospital stay (LOS).
Secondary Outcome Measures
Number of participants requiring oxygen supplementation
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
Number of participants requiring hospital readmission after discharge
Number of adverse events
especially incidence of acute otitis media and pneumonia
Number of participants requiring 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)
30 minutes after intervention and 24 h, 48 h, and 72 h after enrolment
Full Information
NCT ID
NCT06069336
First Posted
September 23, 2023
Last Updated
September 29, 2023
Sponsor
Szpital im. Św. Jadwigi Śląskiej
1. Study Identification
Unique Protocol Identification Number
NCT06069336
Brief Title
Nebulised 3% Hypertonic Saline Versus 0,9% Saline for Treating Patients Hospitalised With Acute Bronchiolitis
Official Title
Nebulised 3% Hypertonic Saline Versus 0,9% Saline for Treating Patients Hospitalised With Acute Bronchiolitis: Protocol of a Randomised, Double-blind, Multicentre Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szpital im. Św. Jadwigi Śląskiej
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
hypertonic saline, infants, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypertonic saline
Arm Type
Active Comparator
Arm 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.
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline
Intervention Description
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
Intervention Name(s)
Normal saline
Intervention Description
0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse
Primary Outcome Measure Information:
Title
Length of hospital stay (LOS).
Time Frame
From admission to hospital discharge
Secondary Outcome Measure Information:
Title
Number of participants requiring oxygen supplementation
Time Frame
During the intervention
Title
The time until the infant will be assessed as being 'fit for discharge'
Description
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
Time Frame
During the intervention
Title
Number of participants requiring hospital readmission after discharge
Time Frame
7 days after the end of interventions
Title
Number of adverse events
Description
especially incidence of acute otitis media and pneumonia
Time Frame
7 days after the end of interventions
Title
Number of participants requiring PICU admission
Description
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.
Time Frame
7 days after the end of interventions
Title
Value of clinical severity score (RDAI and Wang Scale)
Description
30 minutes after intervention and 24 h, 48 h, and 72 h after enrolment
Time Frame
During the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Weeks
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
. Nasal flaring;
Grunting;
Use of accessory muscles;
Intercostal and/or subcostal chest wall retractions;
Apnoe.
Crackles and/or wheezing.
Aged 5 weeks - 24 months old.
A caregiver must provide written informed consent.
Exclusion Criteria:
Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation < 85% on room air).
History of prematurity (gestational age <34 weeks).
Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic).
Immunodeficiency.
Gastro-oesophageal reflux.
Diagnosis or suspicion of asthma.
Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment.
Inhaling bronchodilators within 24 hours before enrolment.
Inhaling steroids within 24 hours before enrolment.
Systemic steroid therapy in the preceding 2 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henryk Szymański, MD
Phone
0048604467073
Email
henryk.t.szymanski@gmail.com
Facility Information:
Facility Name
Szpiatal im.Świętej Jadwigi Śląskiej
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie
City
Warsaw
ZIP/Postal Code
02-091
Country
Poland
Facility Name
Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu
City
Wałbrzych
ZIP/Postal Code
58-309
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The findings of this randomised controlled trial will be submitted to a peer-reviewed journal. Abstracts will be submitted to relevant national and international conferences.
Learn more about this trial
Nebulised 3% Hypertonic Saline Versus 0,9% Saline for Treating Patients Hospitalised With Acute Bronchiolitis
We'll reach out to this number within 24 hrs