High Flow Therapy vs Hypertonic Saline in Bronchiolitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

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).

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Detailed Description

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Conditions

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Acute Viral Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Epinephrine 1/1000

Intervention Type 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

HSS 3%

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Epinephrine 1/1000

Intervention Type 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

HHHFNC

Intervention Type 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

NS (0.9%)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

HSS 3%

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

Intervention Type DRUG

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

Intervention Type DEVICE

NS (0.9%)

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

Intervention Type DRUG

Other Intervention Names

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Adrenaline 1/1000 Adrenalin 1/1000 Normal saline solution 0.9% Physiologic saline solution

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.

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No