Isotonic Saline for Children With Bronchiolitis

NCT ID: NCT05902702

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2029-09-30

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:

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).

Detailed Description

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

Study sites: Seven pediatric departments in eastern Denmark (Slagelse Hospital, Holbæk Hospital, Zealand University Hospital Roskilde, Copenhagen University Hospital Hvidovre, Copenhagen University Hospital Herlev, Nordsjaellands Hospital, and Nykoebing Falster Hospital).

Participants: Children aged 0-12 months admitted to a pediatric department or emergency department in eastern Denmark with bronchiolitis, whose parents provide informed consent for participation.

Randomization: Participating children are randomized 1:1:1 through computer randomization to either nebulized isotonic saline, nasal irrigation with isotonic saline or no isotonic saline therapy at all. Participating children will have a nasal sample collected and tested for a panel of viral pathogens. Excess material (1 ml nasal lining fluid) from upper airway respiratory samples will be stored in a research biobank until 31.12.2030 and used for sub-phenotyping of bronchiolitis and for developing personalized treatment and prediction of later asthma by means of host transcriptomics and metabolomics, 16S sequencing of the airway microbiome and meta-transcriptomics.

All other treatment is given according to standard of care guidelines.

Sample size: By including 249 children in total (83 in each arm) the investigators can prove non-inferiority of nasal irrigation or nebulized saline relative to no saline with a non-inferiority limit of 12 hours admission, alpha 2.5% and a power of 80%. The investigators aim to include 300 children in total to account for dropouts.

Recruitment: Children will only be included if both parents provide informed consent.

Perspectives: This study may improve current practice for supportive treatment of children with bronchiolitis. If saline is found to be helpful, it may be implemented into global guidelines. If no effect of saline is found, physicians may stop spending resources and manpower on an ineffective and potentially unpleasant treatment. Second, if saline is effective, but nasal irrigation proves to be non-inferior to nebulization, it may also reduce the workload of nurses, and possibly duration of hospitalization, because the treatment can be delivered by the parents at home. Moreover, the parents are empowered to manage their child's illness themselves, potentially improving the experience of parents as well as the affected child.

Conditions

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

Study Design

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

Study Groups

Nebulized isotonic saline

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

Group Type: EXPERIMENTAL

Nebulized isotonic saline

Intervention Type: OTHER

The intervention will constitute nebulized isotonic saline.

Nasal irrigation with isotonic saline

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

Group Type: EXPERIMENTAL

Nasal irrigation with isotonic saline

Intervention Type: OTHER

The intervention will constitute isotonic saline administered as nasal drops.

No treatment with saline

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nebulized isotonic saline

The intervention will constitute nebulized isotonic saline.

Intervention Type: OTHER

Nasal irrigation with isotonic saline

The intervention will constitute isotonic saline administered as nasal drops.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: collaborator

Holbaek Sygehus

OTHER

Sponsor Role: collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role: collaborator

Nykøbing Falster Hospital

UNKNOWN

Sponsor Role: collaborator

Slagelse Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann-Marie M Schoos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Slagelse Hospital

Central Contacts

Ann-Marie M Schoos, MD, PhD

Role: CONTACT

annms@regionsjaelland.dk

+45 20681250

Maren J Rytter, MD, PhD

Role: CONTACT

mjry@regionsjaelland.dk

References

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.

Reference Type: DERIVED

PMID: 38233083 (View on PubMed)

Other Identifiers

Bronchiolitis project

Identifier Type: -

Identifier Source: org_study_id