High Flow Therapy vs Hypertonic Saline in Bronchiolitis

Study Overview
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Brief Summary
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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).

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

Conditions
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Acute Viral Bronchiolitis

Intervention / Treatment
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* Drug: Epinephrine 1/1000
* Drug: HSS 3%
* Device: HHHFNC
* Drug: NS (0.9%)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HSS (3%) + epinephrine<br>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<br>* 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<br>* Other names: Adrenalin 1/1000;Drug: HSS 3%<br>* Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria<br>|
| Experimental: HHHFNC+epinephrine+Normal Saline(0.9%)<br>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<br>* 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<br>* Other names: Adrenalin 1/1000;Device: HHHFNC<br>* 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<br>Drug: NS (0.9%)<br>* Nebulization of 2 mL of NS (0.9%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria<br>* Other names: Physiologic saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Every 8h for 6 consecutive times (two days) beginning in the moment of inclusion in the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, Hypertonic saline solution, High-flow oxygen therapy, Respiratory distress, Comfort