Using lung ultrasound to predict outcomes in critically ill infants with respiratory infections

Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection

This study is testing if lung ultrasound can help doctors predict how well critically ill infants with respiratory infections will respond to noninvasive breathing support.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 0 Months to 12 Months
• Sex: All
• Sponsor: Vittore Buzzi Children's Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Milan)
• Trial ID: NCT06425107 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify lung ultrasound findings that are associated with the failure of noninvasive respiratory support in infants with acute lower respiratory tract infections, particularly bronchiolitis. It will compare ultrasound findings from the first 24 hours of ICU stay to those taken one day later to assess clinical improvement. The study focuses on the use of point-of-care lung ultrasound (POCUS) as a non-invasive tool to enhance diagnostic and prognostic capabilities in critically ill infants. By evaluating the lung, pleura, and diaphragm, the study seeks to provide insights into the effectiveness of noninvasive respiratory support methods.

Who should consider this trial

Good fit: Ideal candidates for this study are infants under one year old who are admitted to the PICU for suspected or confirmed lower respiratory tract infections and require noninvasive respiratory support.

Not a fit: Patients who are receiving invasive ventilation or have upper respiratory symptoms only will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the management and outcomes of critically ill infants with respiratory infections by providing timely and accurate prognostic information.

How similar studies have performed: While the use of point-of-care lung ultrasound in respiratory management is gaining traction, this specific application in critically ill infants is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age \<1 year at the time of hospital admission
2. Admission to PICU for suspected/confirmed LRTI
3. Treatment (within the 1st 12 hours of ICU stay) with noninvasive ICU-LRS for respiratory failure (HFNC \>1L/kg/min, negative pressure, or noninvasive PPV via any interface (CPAP, BiPap, NIMV, etc.)

Exclusion Criteria:

1. Invasive ventilation as initial support or within the 1st 12 hours of ICU stay, either via endotracheal tube or tracheostomy
2. Upper respiratory symptoms only (stridor, stertor)
3. Corrected gestational age \<37 weeks at time of ICU admission
4. ICU-LRS for only nonrespiratory reasons (e.g. shock) or for pulmonary edema felt to be solely due to noninfectious causes (cardiogenic, airway obstruction, drowning). Patients presenting with apnea can be included if they have a diagnosis of bronchiolitis or other LRTI
5. Prior inclusion in the study

Where this trial is running

Milan

• Vittore Buzzi Children's Hospital — Milan, Italy (RECRUITING)

Study contacts

• Study coordinator: Anna Camporesi, MD

Conditions: Bronchiolitis, Noninvasive Ventilation