Nasal Irrigation in Infants With Bronchiolitis.
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|ClinicalTrials.gov Identifier: NCT02162745|
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Drug: Isotonic solution (NaCl 0.9%) Drug: Hypertonic solution (NaCl 3%)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis|
|Study Start Date :||October 2012|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
Experimental: Isotonic solution (NaCl 0.9%)
Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril
|Drug: Isotonic solution (NaCl 0.9%)|
Experimental: Hypertonic solution (NaCl 3%)
Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril
|Drug: Hypertonic solution (NaCl 3%)|
No Intervention: Supportive care
Wiping the nose, positioning the child, changing a wet diaper, feeding.
- Oxygen saturation (%) [ Time Frame: up to 50 minutes after allocation ]Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter
- Respiratory effort (WARME score) [ Time Frame: 5, 15, 20, 50 minutes after allocation ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162745
|Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli|
|Pordenone, Friuli Venezia Giulia, Italy, 33170|
|Emergency Department, IRCCS Burlo Garofolo|
|Trieste, Friuli Venezia Giulia, Italy, 34137|
|Study Chair:||Dino Barbi, MD||IRCCS Burlo Garofolo, Trieste, Italy|
|Study Director:||Silvana Schreiber, RN||IRCCS Burlo Garofolo, Trieste, Italy|