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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSS (3%) + epinephrine | Active Comparator | 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. |
|
| HHHFNC+epinephrine+Normal Saline(0.9%) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 criteria were defined. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mercedes Bueno, MD | Department of Pediatrics and Neonatology. Hospital Universitario Fundacion Alcorcon. Madrid. SPAIN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Fundacion Alcorcon | Alcorcón | Madrid | 28922 | Spain | ||
| Hospital Universitario Severo Ochoa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24521787 | Derived | Bueno Campana M, Olivares Ortiz J, Notario Munoz C, Ruperez Lucas M, Fernandez Rincon A, Patino Hernandez O, Calvo Rey C. High flow therapy versus hypertonic saline in bronchiolitis: randomised controlled trial. Arch Dis Child. 2014 Jun;99(6):511-5. doi: 10.1136/archdischild-2013-305443. Epub 2014 Feb 12. |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| 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 |
|
|
| Transfer to PICU at any time during hospitalization |
| Leganés |
| Madrid |
| 28911 |
| Spain |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |