High Flow Therapy vs Hypertonic Saline in Bronchiolitis
Primary Purpose
Acute Viral Bronchiolitis
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Epinephrine 1/1000
HSS 3%
HHHFNC
NS (0.9%)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Viral Bronchiolitis focused on measuring Bronchiolitis, Hypertonic saline solution, High-flow oxygen therapy, Respiratory distress, Comfort
Eligibility Criteria
Inclusion Criteria:
- Children aged 6 months or less
- Moderate (Respiratory Distress Assessment Instrument score of 4 or greater) viral bronchiolitis (as defined by McConnockie)
- Meeting Admission criteria
Exclusion Criteria:
- History of prematurity
- Chronic lung disease
- Cystic fibrosis
- Congenital heart disease
- Neuromuscular disease
- Airway anomalies
- Immunodeficiency
- Those requiring immediate intubation and ventilation.
Sites / Locations
- Hospital Universitario Fundacion Alcorcon
- Hospital Universitario Severo Ochoa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
HSS (3%) + epinephrine
HHHFNC+epinephrine+Normal Saline(0.9%)
Arm Description
Nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of HSS(3%) every 4h for three times and afterwards at physician in charge criteria.
Flow depending on weight (Tidal volume x respiratory rate x 9) and nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of Normal Saline (NS) (0.9%) every 4h and afterwards at physician in charge criteria.
Outcomes
Primary Outcome Measures
Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered
RACS is calculated by combining 2 values: the difference between the Respiratory Distress Assessment Instrument (RDAI) score before and after treatment, plus a value of +1 for each 10% improvement (decrease) in the posttreatment respiratory rate (RR) or a value of -1 for each 10% worsening (increase) in RR.
Secondary Outcome Measures
Difference in mean comfort score along the monitoring period between groups
A scale was used for comfort evaluation . It is based on 4 items: rest, feeding, alertness and facial expression (facial pictures).Minimum 4-Maximum 16
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01873144
Brief Title
High Flow Therapy vs Hypertonic Saline in Bronchiolitis
Official Title
High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Spain
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to demonstrate that heated, humidified, high-flow nasal cannula (HHHFNC) is superior to hypertonic saline solution (HSS) in the treatment of moderate acute viral bronchiolitis in infants in improving respiratory distress and comfort and reducing length of hospital stay (LOS) and admission to Pediatric Intensive Care Unit (PICU).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Viral Bronchiolitis
Keywords
Bronchiolitis, Hypertonic saline solution, High-flow oxygen therapy, Respiratory distress, Comfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HSS (3%) + epinephrine
Arm Type
Active Comparator
Arm Description
Nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of HSS(3%) every 4h for three times and afterwards at physician in charge criteria.
Arm Title
HHHFNC+epinephrine+Normal Saline(0.9%)
Arm Type
Experimental
Arm Description
Flow depending on weight (Tidal volume x respiratory rate x 9) and nebulized solution containing 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 plus 2 mL of Normal Saline (NS) (0.9%) every 4h and afterwards at physician in charge criteria.
Intervention Type
Drug
Intervention Name(s)
Epinephrine 1/1000
Other Intervention Name(s)
Adrenaline 1/1000, Adrenalin 1/1000
Intervention Description
Nebulization of 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 every 4h for three times and afterwards at physician in charge criteria
Intervention Type
Drug
Intervention Name(s)
HSS 3%
Intervention Description
Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
Intervention Type
Device
Intervention Name(s)
HHHFNC
Intervention Description
Precision Flow (Vapotherm Inc. Stevensville, Maryland, US ) and RT329 (Fisher and Paykel Healthcare, Auckland, New Zealand) were the dispositive used depending on the availability. Fisher and Paykel nasal cannula was used in both devices, depending on age
Intervention Type
Drug
Intervention Name(s)
NS (0.9%)
Other Intervention Name(s)
Normal saline solution 0.9%, Physiologic saline solution
Intervention Description
Nebulization of 2 mL of NS (0.9%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
Primary Outcome Measure Information:
Title
Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered
Description
RACS is calculated by combining 2 values: the difference between the Respiratory Distress Assessment Instrument (RDAI) score before and after treatment, plus a value of +1 for each 10% improvement (decrease) in the posttreatment respiratory rate (RR) or a value of -1 for each 10% worsening (increase) in RR.
Time Frame
Every 4h for three consecutive times beginning in the moment of inclusion in the study and after every 8h for three consecutive times (average of 36h)
Secondary Outcome Measure Information:
Title
Difference in mean comfort score along the monitoring period between groups
Description
A scale was used for comfort evaluation . It is based on 4 items: rest, feeding, alertness and facial expression (facial pictures).Minimum 4-Maximum 16
Time Frame
Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study
Other Pre-specified Outcome Measures:
Title
Length of hospital stay (LOS) in days in both groups
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Admission to Pediatric Intensive Care Unit PICU (rate) in both groups
Description
Transfer to PICU criteria were defined.
Time Frame
Transfer to PICU at any time during hospitalization
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 6 months or less
Moderate (Respiratory Distress Assessment Instrument score of 4 or greater) viral bronchiolitis (as defined by McConnockie)
Meeting Admission criteria
Exclusion Criteria:
History of prematurity
Chronic lung disease
Cystic fibrosis
Congenital heart disease
Neuromuscular disease
Airway anomalies
Immunodeficiency
Those requiring immediate intubation and ventilation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercedes Bueno, MD
Organizational Affiliation
Department of Pediatrics and Neonatology. Hospital Universitario Fundacion Alcorcon. Madrid. SPAIN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Universitario Severo Ochoa
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24521787
Citation
Bueno Campana M, Olivares Ortiz J, Notario Munoz C, Ruperez Lucas M, Fernandez Rincon A, Patino Hernandez O, Calvo Rey C. High flow therapy versus hypertonic saline in bronchiolitis: randomised controlled trial. Arch Dis Child. 2014 Jun;99(6):511-5. doi: 10.1136/archdischild-2013-305443. Epub 2014 Feb 12.
Results Reference
derived
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High Flow Therapy vs Hypertonic Saline in Bronchiolitis
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