Actively Recruiting

Age: 0Days - 24Months
All Genders
ID07381790

Modern Technologies for Individual Risk Stratification in Infant Lower Respiratory Tract Infections

Led by Helse Møre og Romsdal HF · Updated on 2026-02-02

200

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Helse Møre og Romsdal HF

Lead Sponsor

S

St. Olavs Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Lower respiratory tract infections (LRTIs) are a leading cause of illness and hospitalization in infants worldwide, especially in low-income areas. In Norway, bronchiolitis, a common viral LRTI affecting small airways, causes breathing and feeding difficulties and can increase the risk of chronic lung disease such as asthma. This observational study aims to improve diagnosis and treatment by using lung ultrasonography (LUS) and tidal breathing flow volume loops (TBFVL) to better assess disease severity and predict long-term outcomes in infants with LRTIs. The study uses modern diagnostic tools including bedside lung ultrasound and tidal flow volume loops to objectively evaluate airway obstruction and lung involvement in hospitalized infants under two years old with LRTIs. Researchers will explore how these tools correlate with clinical symptoms, length of hospital stay, respiratory support needs, and intensive care admissions. The project also includes developing AI-driven scoring for ultrasound images and following patients for 12 months to assess post-infection symptoms and lung function. Participants will undergo lung ultrasound and tidal flow volume loop tests during hospitalization and follow-up visits. Researchers will monitor symptom duration, hospital readmissions, and lung function over a year. The study measures include number of readmissions, hospital stay length, and symptom duration after discharge. This research aims to identify infants at high risk for chronic lung disease to tailor treatments and improve long-term care, while providing caregivers with clearer information about symptom progression and risks.

CONDITIONS

Brief Title

Modern Technologies in Lower Respiratory Tract Infections in Children

Who Can Participate

Age: 0Days - 24Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of lower respiratory tract infection
  • Presence of tachypnea and/or wheezing
  • Signs of retractions
  • Respiratory difficulties
  • Children younger than 24 months old
Not Eligible

You will not qualify if you...

  • Severe congenital heart disease (except ASD, small VSD, PDA)
  • Cystic fibrosis or primary ciliary dyskinesia
  • Neuromuscular diseases or other conditions reducing airway clearance
  • Severe malacia diagnosed by bronchoscopy at baseline
  • Foreign body inhalation
  • Pneumothorax
  • Pleural effusion requiring invasive intervention
  • Bronchopulmonary dysplasia or gestational age less than 32 weeks
  • Caretaker unable to communicate in Norwegian or English
  • Weight less than 3 kg

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 3 days

Participants undergo lung ultrasound and tidal-flow volume loops to assess their lower respiratory tract infections while hospitalized.

1 to 2 visits during hospitalization

Long-term Monitoring

Duration - Up to 12 months

Participants are followed for up to 12 months after baseline to monitor readmissions, symptom duration, and respiratory outcomes.

Follow-up assessments over 12 months

Trial Site Locations

Total: 2 locations

1

Aalesund Hospital

Ålesund, Møre og Romsdal, Norway, 6017

Actively Recruiting

2

St. Olavs Hospital HF

Trondheim, Sør-Trøndelag, Norway, 7030

Not Yet Recruiting

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Research Team

H

Hans Kristian S Ipsen, medical doctor

K

Kari Risnes, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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