High Flow Therapy vs Hypertonic Saline in Bronchiolitis

June 5, 2013 updated by: MªMercedes Bueno Campaña, Ministry of Health, Spain

High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Hospital Universitario Fundación Alcorcón
      • Leganes, Madrid, Spain, 28911
        • Hospital Universitario Severo Ochoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: HSS (3%) + epinephrine
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.
Drug: Epinephrine 1/1000
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
Other Names:
  • Adrenaline 1/1000
  • Adrenalin 1/1000
Drug: HSS 3%
Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
EXPERIMENTAL: HHHFNC+epinephrine+Normal Saline(0.9%)
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.
Drug: Epinephrine 1/1000
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
Other Names:
  • Adrenaline 1/1000
  • Adrenalin 1/1000
Device: HHHFNC
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
Drug: NS (0.9%)
Nebulization of 2 mL of NS (0.9%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
Other Names:
  • Normal saline solution 0.9%
  • Physiologic saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered
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)
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean comfort score along the monitoring period between groups
Time Frame: Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study
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
Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Admission to Pediatric Intensive Care Unit PICU (rate) in both groups
Time Frame: Transfer to PICU at any time during hospitalization
Transfer to PICU criteria were defined.
Transfer to PICU at any time during hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Spain

Investigators

  • Principal Investigator: Mercedes Bueno, MD, Department of Pediatrics and Neonatology. Hospital Universitario Fundacion Alcorcon. Madrid. SPAIN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (ESTIMATE)

June 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 5, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC11-437

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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