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Completed

NCT Number: NCT01873144

High Flow Therapy vs Hypertonic Saline in Bronchiolitis

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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Key information

Conditions

Acute Viral Bronchiolitis Bronchial Diseases Bronchiolitis Bronchitis Dyspnea Infections Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Fundacion Alcorcon, Alcorcón, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Adrenaline 1/1000, Adrenalin 1/1000

HSS 3%

Drug

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

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

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

Other names: Normal saline solution 0.9%, Physiologic saline solution

Primary outcomes

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

    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)

    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 outcomes

  1. Difference in mean comfort score along the monitoring period between groups

    Time frame: 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

Other outcomes

  1. Length of hospital stay (LOS) in days in both groups

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

  2. Admission to Pediatric Intensive Care Unit PICU (rate) in both groups

    Time frame: Transfer to PICU at any time during hospitalization

    Transfer to PICU criteria were defined.

Sponsors and collaborators

Lead sponsor

Ministry of Health, Spain

Other Gov

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 7, 2013
Registry last updated
Jun 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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