Isotonic Saline for Children With Bronchiolitis

NCT05902702 | Not Yet Recruiting

• 1 other identifier: Bronchiolitis project
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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:
• Nebulized isotonic saline
• Nasal irrigation with isotonic saline
• No treatment with saline

Conditions

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

Keywords

Nebulized saline; Nasal saline drops; Nasal saline irrigation; Respiratory severity score

Outcome Measures

Primary Outcomes (1)

• Duration of hospitalization

  In hours

  0-7 days typically (max 14 days)

Secondary Outcomes (11)

• Number of participants needing respiratory support

  During admission (up to day 14)

• Number of participants being readmitted after discharge

  30 days after discharge

• Respiratory severity score

  During admission (up to day 14)

• Number of participants needing oxygen therapy

  During admission (up to day 14)

• Number of participants needing transfer to ICU or SICU

  During admission (up to day 14)

Study Arms (3)

Nebulized isotonic saline

EXPERIMENTAL

5 ml of isotonic saline is administered through a nebulizer with a flow of 10 l oxygen/min

Other: Nebulized isotonic saline

Nasal irrigation with isotonic saline

EXPERIMENTAL

0.5-2 ml isotonic saline in each nostril administered as nasal drops

Other: Nasal irrigation with isotonic saline

No treatment with saline

NO INTERVENTION

These children will not receive any treatment with isotonic saline, but superficial suctioning of nasal secretions as needed (as part of standard care).

Interventions

Nebulized isotonic saline OTHER

The intervention will constitute nebulized isotonic saline.

Nebulized isotonic saline

Nasal irrigation with isotonic saline OTHER

The intervention will constitute isotonic saline administered as nasal drops.

Nasal irrigation with isotonic saline

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 0-12 months, whose parents give informed consent to participate, with symptoms of bronchiolitis including at least one of:
• Runny nose
• Dry and persistent cough
• Labored breathing (tachypnea, retractions, nasal flaring)
• Grunting
• Cyanosis or apnea
• Wheezing or crackles on auscultation
• O2 saturations below 92 %
• Difficulties feeding

You may not qualify if:

• 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).

Sponsors & Collaborators

• Slagelse Hospital: lead
• 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

Related Publications (1)

• Schmidt MN, Daugberg R, Nygaard U, Nielsen XC, Chawes B, Rytter MH, Schoos AM. Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial. BMJ Paediatr Open. 2024 Jan 17;8(1):e002273. doi: 10.1136/bmjpo-2023-002273.

  PMID: 38233083 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Respiration Disorders; Virus Diseases

Interventions

Nasal Lavage; Sodium Chloride

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ann-Marie M Schoos, MD, PhD

  Slagelse Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann-Marie M Schoos, MD, PhD

CONTACT

+45 20681250; annms@regionsjaelland.dk

Maren J Rytter, MD, PhD

CONTACT

mjry@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will receive anonymized data for analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An investigator-initiated, multicenter, open label, three-arm randomized, controlled non-inferiority trial.

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 15, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We have planned to share all IPD with other researchers upon request 5 years after publication.
• Access Criteria: Researchers who request access.