High Flow Therapy vs Hypertonic Saline in Bronchiolitis

NCT01873144 | Completed Phase 3

• 1 other identifier: EC11-437
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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).

Conditions

Acute Viral Bronchiolitis

Keywords

Bronchiolitis; Hypertonic saline solution; High-flow oxygen therapy; Respiratory distress; Comfort

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Difference in mean comfort score along the monitoring period between groups

  Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study

Other Outcomes (2)

• Length of hospital stay (LOS) in days in both groups

  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

  Transfer to PICU at any time during hospitalization

Study Arms (2)

HSS (3%) + epinephrine

ACTIVE COMPARATOR

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; Drug: HSS 3%

HHHFNC+epinephrine+Normal Saline(0.9%)

EXPERIMENTAL

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; Device: HHHFNC; Drug: NS (0.9%)

Interventions

Epinephrine 1/1000 DRUG

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

Also known as: Adrenaline 1/1000, Adrenalin 1/1000

HHHFNC+epinephrine+Normal Saline(0.9%); HSS (3%) + epinephrine

HSS 3% DRUG

Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria

HSS (3%) + epinephrine

HHHFNC DEVICE

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

HHHFNC+epinephrine+Normal Saline(0.9%)

NS (0.9%) DRUG

Nebulization of 2 mL of NS (0.9%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria

Also known as: Normal saline solution 0.9%, Physiologic saline solution

HHHFNC+epinephrine+Normal Saline(0.9%)

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• History of prematurity
• Chronic lung disease
• Cystic fibrosis
• Congenital heart disease
• Neuromuscular disease
• Airway anomalies
• Immunodeficiency
• Those requiring immediate intubation and ventilation.

Sponsors & Collaborators

• Ministry of Health, Spain: lead

Study Sites (2)

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Related Publications (1)

• 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.

  PMID: 24521787 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Dyspnea

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mercedes Bueno, MD

  Department of Pediatrics and Neonatology. Hospital Universitario Fundacion Alcorcon. Madrid. SPAIN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 7, 2013
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

ES (2)