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High Flow Therapy vs Hypertonic Saline in Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MªMercedes Bueno Campaña, Ministry of Health, Spain
ClinicalTrials.gov Identifier:
NCT01873144
First received: May 29, 2013
Last updated: June 5, 2013
Last verified: June 2013
  Purpose
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).

Condition Intervention Phase
Acute Viral Bronchiolitis Drug: Epinephrine 1/1000 Drug: HSS 3% Device: HHHFNC Drug: NS (0.9%) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Flow Therapy vs Hypertonic Saline in Bronchiolitis Treatment. Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by MªMercedes Bueno Campaña, Ministry of Health, Spain:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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.


Enrollment: 75
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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
Other Names:
  • Adrenaline 1/1000
  • Adrenalin 1/1000
Drug: HSS 3%
Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
Experimental: 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.
Drug: 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
Other Names:
  • Adrenaline 1/1000
  • Adrenalin 1/1000
Device: 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
Drug: NS (0.9%)
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

  Eligibility

Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873144

Locations
Spain
Hospital Universitario Fundacion Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital Universitario Severo Ochoa
Leganes, Madrid, Spain, 28911
Sponsors and Collaborators
Ministry of Health, Spain
Investigators
Principal Investigator: Mercedes Bueno, MD Department of Pediatrics and Neonatology. Hospital Universitario Fundacion Alcorcon. Madrid. SPAIN
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MªMercedes Bueno Campaña, Dr, Ministry of Health, Spain
ClinicalTrials.gov Identifier: NCT01873144     History of Changes
Other Study ID Numbers: EC11-437
Study First Received: May 29, 2013
Last Updated: June 5, 2013

Keywords provided by MªMercedes Bueno Campaña, Ministry of Health, Spain:
Bronchiolitis
Hypertonic saline solution
High-flow oxygen therapy
Respiratory distress
Comfort

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Pharmaceutical Solutions
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on July 25, 2017