Using lung ultrasound and breathing-volume measurements to improve care for infants with lower respiratory infections
Official title: Modern Technologies for Individual Risk Stratification in Infant Lower Respiratory Tract Infections
Run by Helse Møre og Romsdal HF · NCT07381790 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 0 Days to 24 Months |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Helse Møre og Romsdal HF Government |
| Locations | 2 sites (Ålesund, Møre og Romsdal and 1 other locations) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT07381790 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.