High Flow Therapy vs Hypertonic Saline in Bronchiolitis

Sponsor

Ministry of Health, Spain (Other)

Overall Status

Completed

CT.gov ID

NCT01873144

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

37.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

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

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Difference in mean Respiratory Assessment Change Score (RACS) between groups in every time considered [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 [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 [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 [Transfer to PICU at any time during hospitalization]
Transfer to PICU criteria were defined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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