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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
Ministry of Health, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

First Posted
May 29, 2013
Last Updated
June 5, 2013
Sponsor
Ministry of Health, Spain
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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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