Nasal Irrigation in Infants With Bronchiolitis.

NCT02162745 | Completed Phase 3

• 1 other identifier: RC 35/12
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; Normal saline solution; Hypertonic solution; Nasal irrigation

Outcome Measures

Primary Outcomes (1)

• Oxygen saturation (%)

  Measurement of arterial oxygen saturation (SpO2) of hemoglobin with digital pulse oximeter

  up to 50 minutes after allocation

Secondary Outcomes (1)

• Respiratory effort (WARME score)

  5, 15, 20, 50 minutes after allocation

Study Arms (3)

Isotonic solution (NaCl 0.9%)

EXPERIMENTAL

Single nasal irrigation with 1 ml of isotonic solution (NaCl 0.9%) per each nostril

Drug: Isotonic solution (NaCl 0.9%)

Hypertonic solution (NaCl 3%)

EXPERIMENTAL

Single nasal irrigation with 1 ml of hypertonic solution (NaCl 3%) per each nostril

Drug: Hypertonic solution (NaCl 3%)

Supportive care

NO INTERVENTION

Wiping the nose, positioning the child, changing a wet diaper, feeding.

Interventions

Isotonic solution (NaCl 0.9%) DRUG

Isotonic solution (NaCl 0.9%)

Hypertonic solution (NaCl 3%) DRUG

Hypertonic solution (NaCl 3%)

Eligibility Criteria

• Age: 1 Day - 365 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (2)

Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli

Pordenone, Friuli Venezia Giulia, 33170, Italy

Location

Emergency Department, IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Isotonic Solutions; Sodium Chloride; Hypertonic Solutions

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Dino Barbi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY CHAIR

• Silvana Schreiber, RN

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

IT (2)