High Flow Therapy vs Hypertonic Saline in Bronchiolitis

Phase 3

Completed

• Conditions: Acute Viral Bronchiolitis
• Interventions: Drug: Epinephrine 1/1000; Drug: HSS 3%; Device: HHHFNC; Drug: NS (0.9%)

• Registration Number: NCT01873144
• Lead Sponsor: Ministry of Health, Spain

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-05-29
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-05
• Last Update Submitted: 2013-06-05
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HSS (3%) + epinephrine	Epinephrine 1/1000	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.
HHHFNC+epinephrine+Normal Saline(0.9%)	Epinephrine 1/1000	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.
HSS (3%) + epinephrine	HSS 3%	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.
HHHFNC+epinephrine+Normal Saline(0.9%)	HHHFNC	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.
HHHFNC+epinephrine+Normal Saline(0.9%)	NS (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.

Primary Outcome Measures

Name	Time	Method
Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered	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.

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (2)

Hospital Universitario Fundacion Alcorcon; 🇪🇸 Alcorcon, Madrid, Spain

Hospital Universitario Severo Ochoa; 🇪🇸 Leganes, Madrid, Spain