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Nasal Irrigation in Infants With Bronchiolitis.

NCT02162745 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2014-06-13

No results posted yet for this study

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

Interventions

DRUG

Isotonic solution (NaCl 0.9%)

DRUG

Hypertonic solution (NaCl 3%)

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Dino Barbi, MD · IRCCS Burlo Garofolo, Trieste, Italy

  • Silvana Schreiber, RN · IRCCS Burlo Garofolo, Trieste, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
365 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02162745 on ClinicalTrials.gov