Nasal Irrigation in Infants With Bronchiolitis.

NCT ID: NCT02162745

Last Updated: 2014-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Isotonic solution (NaCl 0.9%)

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

Group Type: EXPERIMENTAL

Isotonic solution (NaCl 0.9%)

Intervention Type: DRUG

Hypertonic solution (NaCl 3%)

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

Group Type: EXPERIMENTAL

Hypertonic solution (NaCl 3%)

Intervention Type: DRUG

Supportive care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Isotonic solution (NaCl 0.9%)

Intervention Type: DRUG

Hypertonic solution (NaCl 3%)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 365 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Ronfani Luca

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dino Barbi, MD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo, Trieste, Italy

Silvana Schreiber, RN

Role: STUDY_DIRECTOR

IRCCS Burlo Garofolo, Trieste, Italy

Locations

Pediatria, Azienda Ospedaliera Santa Maria Degli Angeli

Pordenone, Friuli Venezia Giulia, Italy

Emergency Department, IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, Italy

Countries

Italy

Other Identifiers

RC 35/12

Identifier Type: -

Identifier Source: org_study_id