Lung Ultrasound for Breathing Difficulties in Newborns

Recruiting at 1 trial location

Overseen By Meg Baker

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Congenital disease, Parents under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether lung ultrasounds can predict if newborns with breathing difficulties will successfully come off a breathing tube. It focuses on infants in the NICU who need breathing support due to respiratory distress. The trial involves taking an ultrasound of the lungs before and after removing the breathing tube. A suitable candidate for this trial is a newborn at UnityPoint Health Meriter Hospital or the University of Minnesota's NICU, who has been intubated and is deemed ready for extubation by their doctor. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve care for newborns with respiratory distress.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that lung ultrasound is safe for newborns?

Research shows that lung ultrasound is a safe and effective method for assessing breathing problems in newborns. Studies have found that clinicians often use it at the bedside to evaluate babies with respiratory issues. Guidelines indicate that lung ultrasounds are highly accurate, with a 92-99% chance of correctly identifying babies with breathing problems and a 95-97% chance of ruling out those without. This accuracy allows for precise identification of affected and unaffected infants. Importantly, no studies have reported harmful effects from using lung ultrasounds on newborns, making it a well-tolerated option for assessing breathing difficulties in infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using lung ultrasound for newborns with breathing difficulties because it offers a non-invasive way to assess lung function before and after extubation. Unlike traditional methods like chest X-rays, which expose infants to radiation, lung ultrasound is safer and can be performed at the bedside. This technique provides real-time images, allowing doctors to make quicker and more informed decisions about a newborn's respiratory care.

What evidence suggests that lung ultrasound is effective for predicting extubation success in newborns with respiratory distress?

Research has shown that lung ultrasound (LUS), which participants in this trial will undergo, effectively diagnoses breathing problems in newborns. Studies indicate it correctly identifies babies with breathing issues 92–99% of the time and accurately recognizes healthy babies 95–97% of the time. This means LUS excels at detecting babies with breathing problems without mistakenly labeling healthy ones as sick. LUS is also easy to learn and safe because it doesn't use harmful radiation. Early evidence suggests that using LUS reduces the chance of misdiagnosis, leading to better outcomes for newborns with breathing difficulties. ^{1 3 4 5 6}

Who Is on the Research Team?

Adam S Bauer, MD

Principal Investigator

Meriter Foundation

Are You a Good Fit for This Trial?

This trial is for infants in the NICU with respiratory distress needing a breathing tube, who are ready to try breathing without it according to their doctor. They must be born at specific hospitals. Babies with major birth defects or those whose parents are minors cannot participate.

Inclusion Criteria

My baby is ready to breathe without a machine, as confirmed by the neonatologist.

Babies born at UnityPoint Health Meriter Hospital and University of Minnesota who need a breathing tube in the Neonatal Intensive Care Unit (NICU) because of breathing problems.

Exclusion Criteria

My baby's parents are under 18.

I do not have any major congenital diseases like heart or lung malformations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-extubation Assessment

Participants undergo a lung ultrasound 12 hours before extubation to assess readiness

12 hours

1 visit (in-person)

Post-extubation Monitoring

Participants undergo a lung ultrasound and are monitored for extubation success and changes in vital signs

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after extubation, including time to re-intubation

72 hours

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound

Trial Overview The study is testing if lung ultrasounds can help predict whether babies with breathing difficulties can successfully breathe on their own after having their breathing tubes removed.

How Is the Trial Designed?

Group I: Lung ultrasound Experimental Treatment 1 Intervention

Participants undergo pre- and post-extubation lung ultrasound

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

UnityPoint Health-Meriter

Collaborator

Trials

2

Recruited

240+

Meriter Foundation

Collaborator

Trials

8

Recruited

3,600+

Published Research Related to This Trial

Lung ultrasound performed by neonatologists at the bedside is a reliable and accurate method for diagnosing and managing various neonatal respiratory conditions, such as respiratory distress syndrome and bronchopulmonary dysplasia.

The use of lung ultrasound can help predict morbidity and guide invasive interventions, highlighting its potential as a valuable diagnostic tool in neonatal intensive care units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Ultrasound in the Neonatal Intensive Care Unit: Does It Impact Clinical Care? Ruoss, JL., Bazacliu, C., Cacho, N., et al.[2021]

Lung ultrasound (LUS) is effective in quickly assessing lung aeration and airway liquid clearance in healthy newborns, with complete liquid clearance typically achieved within the first 4 hours after birth.

In a study of 115 infants, LUS showed that all newborns had established pleural lines within 2 minutes, and only 14% had significant liquid retention at 10 minutes, indicating rapid adaptation after birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound immediately after birth to describe normal neonatal transition: an observational study. Blank, DA., Kamlin, COF., Rogerson, SR., et al.[2018]

Lung ultrasound (LUS) effectively identifies and evaluates the severity of bronchopulmonary dysplasia (BPD) in preterm infants, with significant differences in ultrasound features between moderate-to-severe and none-to-mild BPD groups.

In the study of 108 infants, LUS showed high sensitivity (91.1%) and negative predictive value (91.3%) for detecting moderate-to-severe BPD, making it a reliable, radiation-free imaging technique for assessing this common chronic lung disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of lung ultrasound imaging in preterm infants with bronchopulmonary dysplasia. Sun, YH., Yuan, L., Du, Y., et al.[2022]

Lung ultrasound (LUS) is a safe and effective tool for diagnosing respiratory diseases in neonates, as it can be performed at the bedside without the risks associated with radiation.

LUS findings are consistent and repeatable across various neonatal respiratory conditions, making it a valuable extension of the clinical examination for real-time diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound: diagnostic and therapeutic issues. Cattarossi, L.[2018]

Early lung ultrasound can effectively predict which neonates with respiratory distress will need mechanical ventilation, with a high sensitivity of 95% and a negative predictive value of 98.5%.

In a study of 105 neonates, those classified as high-risk by lung ultrasound had a significantly higher rate of intubation (20%) compared to the low-risk group, indicating its potential to guide clinical decisions in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Ultrasound as a Predictor of Mechanical Ventilation in Neonates Older than 32 Weeks. Rodríguez-Fanjul, J., Balcells, C., Aldecoa-Bilbao, V., et al.[2022]

Lung ultrasound is a reliable and accurate method for diagnosing various lung diseases in newborns, such as respiratory distress syndrome and pneumonia, which were traditionally diagnosed using X-rays or CT scans.

The use of lung ultrasound offers significant advantages, including no radiation exposure, lower costs, and the ability to perform examinations conveniently at the bedside in neonatal wards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasonography for the diagnosis of neonatal lung disease. Liu, J.[2016]

Lung ultrasound (LU) is a quick, easy, and non-irradiating diagnostic tool that provides accurate information about lung conditions, making it particularly useful in critical care and emergency settings.

In neonates, LU can effectively predict the need for hospital admission and intubation based on specific ultrasound patterns, and a newly proposed LU score correlates well with oxygenation status, aiding in the treatment of preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lung ultrasound in the newborn]. Yousef, N.[2017]

Implementing lung ultrasound (LUS) as the first-line imaging technique for newborns with respiratory distress significantly reduced the number of chest X-rays (CXR) performed, leading to lower radiation exposure per infant.

The use of LUS did not negatively impact clinical outcomes, as respiratory support needs and complications remained similar between the two groups, indicating that LUS is a safe and effective alternative to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound protocol decreases radiation in newborn population without side effects: A quality improvement project. Rodriguez-Fanjul, J., Benet, N., Rodrigo Gonzalo de Lliria, C., et al.[2023]

Lung ultrasound (LUS) is a safe, radiation-free imaging technique that can be used at the bedside in neonatology to assess respiratory disorders, providing a cost-effective and efficient diagnostic tool.

The review introduces the SAFE protocol (Sonographic Algorithm for liFe threatening Emergencies) for emergency LUS applications in critical neonates, which aims to standardize decision-making for interventions like surfactant administration and chest drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Raimondi, F., Yousef, N., Migliaro, F., et al.[2023]

Lung ultrasound (LUS) has been shown to accurately correlate with lung air volumes measured by high-resolution CT scans in newborn lambs, indicating its potential as a reliable tool for assessing lung aeration after birth.

The study found that LUS can predict the proportion of air in the lungs with moderate accuracy, suggesting it could help tailor aeration strategies for critically ill newborns in real-time, reducing reliance on X-ray imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying lung aeration in neonatal lambs at birth using lung ultrasound. Pryor, EJ., Blank, DA., Hooper, SB., et al.[2022]

Lung ultrasound (LU) is widely used in 82% of Italian neonatal intensive care units (NICUs) as a noninvasive diagnostic tool for various respiratory conditions, with pneumothorax and respiratory distress syndrome being the most common applications.

Despite its popularity, the use of LU varies significantly across centers, highlighting the need for standardized clinical guidelines and formal training programs to ensure consistent and effective use of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound in Italian neonatal intensive care units: A national survey. Corsini, I., Parri, N., Ficial, B., et al.[2022]

Lung ultrasound (LUS) demonstrated high sensitivity (95.6%) and specificity (94.4%) for diagnosing respiratory distress syndrome (RDS) in a study of 59 neonates, indicating it is a reliable diagnostic tool.

For transient tachypnea of the newborn (TTN), LUS also showed strong performance with a sensitivity of 93.3% and specificity of 96.5%, suggesting it can effectively differentiate between these neonatal respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung ultrasound accuracy in respiratory distress syndrome and transient tachypnea of the newborn. Vergine, M., Copetti, R., Brusa, G., et al.[2016]

In a study of 956 neonates in two NICUs, point of care lung ultrasound (POC-LUS) was performed 4076 times, showing a significant increase in usage from 316 studies in 2016 to 1257 in 2020.

POC-LUS led to a change in clinical management for 62% of the studies conducted, indicating its effectiveness in influencing treatment decisions for neonates in the NICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point of care lung ultrasound service in neonatal intensive care: Five years of experience in Manitoba, Canada. Elsayed, Y., Narvey, M., Lashin, A., et al.[2022]

Citations

1. tandfonline.com tandfonline.com/doi/full/10.1080/14767058.2023.2206943

Ultrasound diagnosis and grading criteria of neonatal ... The management of RDS under lung ultrasound (LUS) monitoring has achieved significant results, reducing the misdiagnosis rate of RDS, thereby reducing the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674376/

Lung Ultrasound in Neonatal Respiratory Distress Syndrome Numerous studies highlight the benefits of LUS in newborns due to its ease of learning, bedside accessibility, reproducibility, and non-ionizing ...

3. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-025-03879-5

Guidelines for the use of lung ultrasound to optimise the ... According to the scientific literature, LUS has high sensitivity (92–99%) and specificity (95–97%) in diagnosing neonatal respiratory distress ...

4. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2025.1631563/full

Breathe easy, baby, breathe. Lung ultrasound in neonatal ... This review emphasizes the role of LUS in neonates with acute respiratory distress as a fundamental component of the point-of-care ultrasound ( ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2024/11080/the_value_of_lung_ultrasound_in_the_differential.83.aspx

The value of lung ultrasound in the differential diagnosis... The detection rate of lung ultrasound examination for lung disease in newborns was 85.00%, with a sensitivity of 95.77%, specificity of 77.77%, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9857438/

Lung Ultrasound Role in Diagnosis of Neonatal ... This study assesses the utility of LUS for neonatal respiratory disorders (NRDs) diagnosis and follow-up compared to chest X-ray (CXR).