High Flow Therapy vs Hypertonic Saline in Bronchiolitis

Ministry of Health, Spain75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Viral Bronchiolitis

Interventions

Epinephrine 1/1000DRUG

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

HSS 3%DRUG

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

HHHFNCDEVICE

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

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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.

Locations (2)

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Outcomes

Primary Outcomes

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.

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 Outcomes

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.