Isotonic Saline for Children With Bronchiolitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-12
SponsorSlagelse Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Runny nose

Dry and persistent cough

Labored breathing (tachypnea, retractions, nasal flaring)

Grunting

Disqualifiers

Children with cystic fibrosis or other serious congenital lung diseases

Children in whom treatment with short-acting beta-2 agonist is initiated (as this is delivered in nebulized isotonic saline).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nebulized isotonic saline

    Other intervention

    The intervention will constitute nebulized isotonic saline.

  • Nasal irrigation with isotonic saline

    Other intervention

    The intervention will constitute isotonic saline administered as nasal drops.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Nebulized isotonic salineExperimental treatment 1 intervention
Group B: Nasal irrigation with isotonic salineExperimental treatment 1 intervention
Group C: No treatment with salineNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Duration of hospitalization

In hours

Time frame
0-7 days typically (max 14 days)

Secondary outcomes

1

Number of participants needing respiratory support

The need for respiratory support with nasal continuous positive airway pressure or high-flow oxygen therapy.

Time frame
During admission (up to day 14)
2

Number of participants being readmitted after discharge

If readmitted to the hospital

Time frame
30 days after discharge
3

Respiratory severity score

Respiratory Severity Score with Heart Rate (RSS-HR), scale from 0-12, higher score means worse outcome.

Time frame
During admission (up to day 14)
4

Number of participants needing oxygen therapy

Need for oxygen therapy

Time frame
During admission (up to day 14)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Slagelse Hospital

Lead sponsor

Copenhagen University Hospital at Herlev

Collaborator

Zealand University Hospital

Collaborator

Copenhagen University Hospital, Hvidovre

Collaborator

Holbaek Sygehus

Collaborator

Nordsjaellands Hospital

Collaborator

Nykøbing Falster Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: