High Flow Therapy vs Hypertonic Saline in Bronchiolitis

Acute Viral Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873144
• Other study ID #: EC11-437
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2013
• Last updated: June 5, 2013
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Ministry of Health, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Viral Bronchiolitis
• Bronchiolitis
• Bronchiolitis, Viral

Intervention

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

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

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcon	Madrid
Spain	Hospital Universitario Severo Ochoa	Leganes	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay (LOS) in days in both groups		Participants will be followed for the duration of hospital stay, an expected average of 5 days	No
Other	Admission to Pediatric Intensive Care Unit PICU (rate) in both groups	Transfer to PICU criteria were defined.	Transfer to PICU at any time during hospitalization	No
Primary	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)	No
Secondary	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	No