Modern Technologies in Lower Respiratory Tract Infections in Children

NCT07381790 | Recruiting

• 1 other identifier: 940358
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Lower respiratory tract infections (LRTIs) are a significant cause of childhood morbidity and mortality globally, particularly in low-income countries. In Norway, LRTIs is a leading cause of hospitalization among infants, representing a great socioeconomic burden. Bronchiolitis, a viral infection, is the main representation of LRTIs in infants. It affects the small airways, causing breathing- and feeding difficulties. Today, treatment relies on subjective evaluations, lacking objective measures for assessment. This increases the risk of both under- and over treating patients. In the long term, bronchiolitis increases risk of asthma, but it is unknown who the high-risk patients for chronic lung disease are. Lung ultrasonography (LUS) has emerged as a promising tool for assessing bronchiolitis severity and progression of the disease. The investigators will explore its use to improve diagnostic accuracy and treatment decisions, and develop AI-driven scoring tools for novel technology. Additionally, tidal breathing flow volume loops (TBFVL) offer a non-invasive method for evaluating airway obstruction in infants, with the potential to assess severity of bronchiolitis, treatment efficacy and post-infection lung function. In this project the investigators will combine the use of these modern technologies to improve treatment and follow-up of infants with LRTIs. The main aim for this observational study is to assess the utility of lung ultrasonography (LUS) and tidal flow volume loops (TBFVL) in infant lower respiratory tract infections (LRTIs) for individual risk stratification in acute and chronic settings. This aims to refine the management of bronchiolitis, identifying high-risk patients for chronic lung disease to tailor treatment and follow-up protocols. The project has three secondary objectives.

1. 1.To assess correlation between LUS and TBFVL findings with clinical score at admission, length of stay, need of respiratory support and ICU admissions.
2. 2.To assess duration of symptoms following acute bronchiolitis and evaluate the use of LUS and TBFVL in objectively examine post-infectious sequela.
3. 3.To evaluate the long-term impact of bronchiolitis on lung function through clinical follow-up after a 12 month period.

Conditions

Pediatric Lung Ultrasound; Bronchiolitis Acute; Lower Respiratory Tract and Lung Infections; Tidal Volume; Pediatric Lung Diagnosis; Pediatric Asthma

Keywords

pediatric; lung ultrasound; lower respiratory tract infections; tidal-flow volume loops

Outcome Measures

Primary Outcomes (3)

• Number of readmissions at 1 year follow-up after baseline.

  All participants will be followed for 1 year after first hospitalization with LRTI. At that point investigators will retrieve data on readmissions as primary outcome, correlated with initial findings.

  From enrollment to the end of follow-up at 12 months.

• Length of stay at hospital due to LRTI.

  Primay outcome is length of stay at hospital, correlated with findings at hospitalization (lung ultrasound and tidal-flow volume loops)

  from enrollment to discharge from hospital, average patient is hospitalized 3 days.

• Duration of symptoms after hospitalization due to LRTI.

  duration of symptoms after hospitalization with lower respiratory tract infection, marked by symptom diary and follow-up by phone call. Participants are deemed free of symptoms when they are in habitual state without cough.

  from enrollment to weeks/months after discharge, based on reporting of symptoms. Up to 60 days.

Secondary Outcomes (1)

• Use of respiratory support correlated with lung ultrasound score and tidal-flow volume loop results

  form enrollment to discharge from hospital, average hospitalization is 3 days.

Study Arms (1)

children under 2 years of age, hospitalized with lower respiratory tract infection

Diagnostic Test: lung ultrasound; Diagnostic Test: Tidal-flow volume loops

Interventions

lung ultrasound DIAGNOSTIC_TEST

performance of lung utltrasound in participants, performed bedside (v scan).

children under 2 years of age, hospitalized with lower respiratory tract infection

Tidal-flow volume loops DIAGNOSTIC_TEST

tidal-flow volume loops performed in patients hospitalized with lower respiratory tract infections.

children under 2 years of age, hospitalized with lower respiratory tract infection

Eligibility Criteria

• Age: 0 Days - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children under 2 years of age, hospitalized with lower respiratory tract infections. single cohort study.

You may qualify if:

• clinical diagnosis of lower respiratory tract infection
• with tachypnea and/or
• wheezing
• Retractions
• Respiratory difficulties

You may not qualify if:

• Severe Congenital heart disease (not ASD, small VSD, PDA)
• Cystic fibrosis and PCD
• Neuromuscular diseases and other diseases with reduced airway clearance
• Severe malacia, diagnosed by bronchoscopy by time of T0.
• Foreign body inhalation
• Pneumothorax
• Pleural effusion (with need of invasive interventions)
• Bronchopulmonary dysplasia or GA \<32 weeks
• Caretaker not able to communicate in Norwegian or English
• Weight \<3 kg

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• St. Olavs Hospital: collaborator

Study Sites (2)

Aalesund Hospital

Ålesund, Møre og Romsdal, 6017, Norway

RECRUITING

St. Olavs Hospital HF

Trondheim, Sør-Trøndelag, 7030, Norway

NOT YET RECRUITING

Central Study Contacts

Hans Kristian S Ipsen, medical doctor

CONTACT

+4770105000; hans.kristian.ipsen@helse-mr.no

Kari Risnes, Professor

CONTACT

+4772573000; kari.risnes@ntnu.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: February 2, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)