Acute Viral Bronchiolitis
Conditions
Keywords
Bronchiolitis, Hypertonic saline solution, High-flow oxygen therapy, Respiratory distress, Comfort
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).
Interventions
DRUGEpinephrine 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
DRUGHSS 3%
Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
DEVICEHHHFNC
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
DRUGNS (0.9%)
Nebulization of 2 mL of NS (0.9%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
Sponsors
Ministry of Health, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed