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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
Sponsor:
Information provided by (Responsible Party):
Ronfani Luca, IRCCS Burlo Garofolo

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Efficacy of Nasal Irrigation in Infants With Bronchiolitis
Study Start Date : October 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Oxygen saturation (%) [ Time Frame: up to 50 minutes after allocation ]
    Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants <1 year
  • diagnosis of bronchiolitis with respiratory distress, rhinitis, cough
  • oxygen saturation between 88 and 94%

Exclusion Criteria:

  • previous treatments (nasal irrigation or suctioning, oxygen, nebulized drugs, nebulized hypertonic solution, antipyretics up to 6 hours before the study entry, oral steroids at any time before study entry)
  • chronic illness

Information from the National Library of Medicine

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


Locations
Italy
Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli
Pordenone, Friuli Venezia Giulia, Italy, 33170
Emergency Department, IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Study Chair: Dino Barbi, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Silvana Schreiber, RN IRCCS Burlo Garofolo, Trieste, Italy

Responsible Party: Ronfani Luca, MD, PhD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT02162745     History of Changes
Other Study ID Numbers: RC 35/12
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014

Keywords provided by Ronfani Luca, IRCCS Burlo Garofolo:
Bronchiolitis
Normal saline solution
Hypertonic solution
Nasal irrigation

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pharmaceutical Solutions