Isotonic Saline for Children With Bronchiolitis

Summary

The goal of this randomized clinical trial is to investigate the optimal supportive treatment of bronchiolitis in infants from 0-12 months of age. The main question\[s\] it aims to answer are:

* To investigate whether isotonic saline should be used as supportive treatment for children with bronchiolitis, and if so, identify the optimal route of administration. The primary outcome is duration of hospitalization.
* To investigate the current epidemiology of the viral pathogens causing bronchitis in children in Denmark, and to assess whether children infected with specific pathogens might benefit from treatment with isotonic saline.

The children are randomized after inclusion through computer randomization to one of the 3 arms in the study:

1. Nebulized isotonic saline
2. Nasal irrigation with isotonic saline
3. No treatment with saline

The investigators will compare treatment with saline (both methods) with no treatment, and the investigators will also compare the two methods of delivery of saline (nebulized vs. nasal irrigation).

Conditions

• Bronchiolitis
• Respiratory Disease
• Asthma in Children
• Viral Infection
• Acute Respiratory Infection

Interventions

OTHER

Nebulized isotonic saline

The intervention will constitute nebulized isotonic saline.

OTHER

Nasal irrigation with isotonic saline

The intervention will constitute isotonic saline administered as nasal drops.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Holbaek Sygehus

  collaborator OTHER

• Nordsjaellands Hospital

  collaborator OTHER

• Nykøbing Falster Hospital

  collaborator UNKNOWN

• Slagelse Hospital

  lead OTHER

Principal Investigators

• Ann-Marie M Schoos, MD, PhD · Slagelse Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-30

Primary Completion

2024-09-30

Completion

2029-09-30