Using lung ultrasound and breathing-volume measurements to improve care for infants with lower respiratory infections
Modern Technologies for Individual Risk Stratification in Infant Lower Respiratory Tract Infections
This project will try lung ultrasound and tidal-flow volume measurements to see if they give clearer, objective information for infants and young children with lower respiratory infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 0 Days to 24 Months |
| Sex | All |
| Sponsor | Helse Møre og Romsdal HF Government |
| Locations | 2 sites (Ålesund, Møre og Romsdal and 1 other locations) |
| Trial ID | NCT07381790 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll infants and children with clinical lower respiratory tract infections at two Norwegian hospitals and perform bedside lung ultrasound and tidal-flow volume loop measurements alongside routine clinical care. Investigators will collect clinical signs, outcomes, and imaging data to correlate ultrasound and flow-loop patterns with disease severity and short-term course. The team will develop and pilot AI-driven scoring tools to standardize interpretation and explore whether these tools help guide treatment decisions. Patients with major comorbidities or conditions that preclude safe testing are excluded, and no experimental therapeutics are given.
Who should consider this trial
Good fit: Infants and children presenting with a clinical diagnosis of lower respiratory tract infection with tachypnea, wheeze, retractions, or respiratory difficulty, weighing at least 3 kg and with caregivers able to communicate in Norwegian or English, are ideal candidates.
Not a fit: Children with severe congenital heart disease (except small defects like ASD/VSD/PDA), cystic fibrosis, primary ciliary dyskinesia, neuromuscular disorders, severe airway malacia, active pneumothorax or pleural effusion needing intervention, bronchopulmonary dysplasia or gestational age under 32 weeks, or those unable to attend the study sites are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could provide objective bedside measures that reduce under- or overtreatment and help identify children at higher risk for chronic lung problems.
How similar studies have performed: Prior research supports lung ultrasound as a promising tool in bronchiolitis, but combining it with tidal-flow loop data and AI-driven scoring is relatively new and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinical diagnosis of lower respiratory tract infection * with tachypnea and/or * wheezing * Retractions * Respiratory difficulties Exclusion Criteria: * 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
Where this trial is running
Ålesund, Møre og Romsdal and 1 other locations
- Aalesund Hospital — Ålesund, Møre og Romsdal, Norway (Recruiting)
- St. Olavs Hospital HF — Trondheim, Sør-Trøndelag, Norway (Not_yet_recruiting)
Study contacts
- Study coordinator: Hans Kristian S Ipsen, medical doctor
- Email: hans.kristian.ipsen@helse-mr.no
- Phone: +4770105000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.