Lung Ultrasound for Breathing Difficulties in Newborns

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Adam S Bauer, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Congenital disease, Parents under 18

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine whether lung ultrasound can predict extubation success in neonates with respiratory distress. Participants will undergo a lung ultrasound pre- and post-extubation.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Ultrasound Imaging for breathing difficulties in newborns?

Research shows that lung ultrasound is reliable and accurate in diagnosing and managing breathing problems in newborns, such as respiratory distress syndrome and pneumonia. It is a quick, safe, and effective tool that can be used at the bedside without exposing babies to radiation. ^{1 2 3 4 5}

Is lung ultrasound safe for newborns?

Lung ultrasound is considered safe for newborns as it is a non-invasive, radiation-free imaging technique that can be used at the bedside without risks. ^{6 7 8 9 10}

How is lung ultrasound different from other treatments for breathing difficulties in newborns?

Lung ultrasound is unique because it is a noninvasive, bedside imaging technique that helps doctors accurately diagnose and manage breathing problems in newborns without needing to move them to another location. Unlike other treatments that might involve more invasive procedures, lung ultrasound provides real-time information to guide care directly at the bedside. ^{1 10 11 12 13}

Research Team

Adam S Bauer, MD

Principal Investigator

Meriter Foundation

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Ultrasound (Procedure)

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.

Participant Groups

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+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

UnityPoint Health-Meriter

Collaborator

Trials

2

Recruited

240+

Meriter Foundation

Collaborator

Trials

8

Recruited

3,600+

Findings from Research

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]

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]

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]

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) 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) 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Lung Ultrasound in the Neonatal Intensive Care Unit: Does It Impact Clinical Care? [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Lung Ultrasound as a Predictor of Mechanical Ventilation in Neonates Older than 32 Weeks. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. France pubmed.ncbi.nlm.nih.gov

[Lung ultrasound in the newborn]. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Point of care lung ultrasound service in neonatal intensive care: Five years of experience in Manitoba, Canada. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Lung ultrasound: diagnostic and therapeutic issues. [2018]

7. Spain pubmed.ncbi.nlm.nih.gov

Lung ultrasound protocol decreases radiation in newborn population without side effects: A quality improvement project. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Quantifying lung aeration in neonatal lambs at birth using lung ultrasound. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Lung ultrasound in Italian neonatal intensive care units: A national survey. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Lung ultrasound immediately after birth to describe normal neonatal transition: an observational study. [2018]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Characterization of lung ultrasound imaging in preterm infants with bronchopulmonary dysplasia. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Lung ultrasound accuracy in respiratory distress syndrome and transient tachypnea of the newborn. [2016]