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Bronchiolitis is a leading cause of acute illness and hospitalization in the first year of life. Most children with bronchiolitis have mild disease and are managed at home with support from primary care providers, while children with more severe symptoms require supportive therapy with oxygen and fluid administration.
Neonates may be obligate nasal breathers until they are at least 2 months old and nasal obstruction may play a relevant role in respiratory resistances throughout the first months of life, whereas nasal passages may exhibit as much as 50% of the total airway resistance. Some guidelines recommend to clear the nostrils of secretions to improve airway patency but no controlled trial on the efficacy of nasal irrigation in infants with bronchiolitis was carried out.
The aim of this randomized controlled trial is to compare normal saline and hypertonic solution for nasal irrigation versus simple supportive care in infants admitted to Emergency Department with bronchiolitis and mild desaturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotonic solution (NaCl 0.9%) | Experimental | Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril |
|
| Hypertonic solution (NaCl 3%) | Experimental | Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril |
|
| Supportive care | No Intervention | Wiping the nose, positioning the child, changing a wet diaper, feeding. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotonic solution (NaCl 0.9%) | Drug |
| ||
| Hypertonic solution (NaCl 3%) |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation (%) | Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter | up to 50 minutes after allocation |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory effort (WARME score) | Evaluation of the respiratory effort using the validated WARME score (evaluation of: 1) respiratory rate; 2) prolonged expiration; 2) wheezing; 3) air exchange; 4) muscle use). | 5, 15, 20, 50 minutes after allocation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dino Barbi, MD | IRCCS Burlo Garofolo, Trieste, Italy | Study Chair |
| Silvana Schreiber, RN | IRCCS Burlo Garofolo, Trieste, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli | Pordenone | Friuli Venezia Giulia | 33170 | Italy | ||
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012965 | Sodium Chloride |
| D006982 | Hypertonic Solutions |
| ID | Term |
|---|---|
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| Drug |
|
| Emergency Department, IRCCS Burlo Garofolo |
| Trieste |
| Friuli Venezia Giulia |
| 34137 |
| Italy |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |