Nasal Irrigation in Infants With Bronchiolitis.

IRCCS Burlo Garofolo

Status and phase: Completed; Phase 3

Conditions: Bronchiolitis

Treatments: Drug: Hypertonic solution (NaCl 3%); Drug: Isotonic solution (NaCl 0.9%)

Study type: Interventional

Funder types: Other

Identifiers

NCT02162745

RC 35/12

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 1 to 365 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

133 participants in 3 patient groups

Isotonic solution (NaCl 0.9%)

Experimental group

Description:

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

Treatment:

Drug: Isotonic solution (NaCl 0.9%)

Hypertonic solution (NaCl 3%)

Experimental group

Description:

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

Treatment:

Drug: Hypertonic solution (NaCl 3%)

Supportive care

No Intervention group

Description:

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