12 Participants Needed

Quantitative Ultrasound for Fetal Lung Assessment

SB
UO
Overseen ByUW Ob/Gyn Human Subjects Core
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of ultrasound called backscatter quantitative ultrasound (bQUS) to determine its effectiveness in checking a baby's lungs around 36 weeks of pregnancy. The goal is to assess whether this method reliably evaluates lung health in unborn babies. Women between 32 and 36 weeks pregnant with one baby and not in labor may qualify for this study. Participants will undergo a single 30-minute ultrasound between 32 and 36 weeks of pregnancy. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could enhance prenatal care.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are prescribed corticosteroids, you cannot participate in the trial.

What prior data suggests that this ultrasound technique is safe for fetal lung assessment?

Research has shown that backscatter quantitative ultrasound (bQUS) is a safe method for checking a baby's lungs. Ultrasound, widely used during pregnancy, is non-invasive and easy to handle. Studies have found that ultrasound, including the bQUS method, safely examines the baby, with no harmful effects reported for either the baby or the mother. This method gives doctors important information without causing discomfort or risk. Therefore, participants in the trial can expect a safe experience with this type of ultrasound.12345

Why are researchers excited about this trial?

Researchers are excited about using backscatter quantitative ultrasound for fetal lung assessment because it offers a non-invasive and radiation-free way to evaluate lung development in unborn babies. Unlike traditional methods like amniocentesis or MRI, which can be invasive or expensive, this ultrasound technique provides immediate results without risk to the mother or fetus. It's a promising tool for early detection of potential lung issues, which can lead to more timely and effective interventions.

What evidence suggests that backscatter quantitative ultrasound is effective for fetal lung assessment?

Revised FAQ Answer:

Initial findings suggest that backscatter quantitative ultrasound (bQUS), studied in this trial, could be a promising tool for assessing a baby's lung maturity before birth. Research has shown that bQUS can accurately measure lung development. One study predicted lung maturity with up to 96.4% accuracy using this technology. Another study found it reliably identified babies at risk for breathing problems after birth. These studies suggest that bQUS could help doctors better understand and prepare for newborn lung health.26789

Who Is on the Research Team?

JI

J. Igor Iruretagoyena, MD, MS

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

Inclusion Criteria

My pregnancy's age was confirmed by ultrasound.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Feasibility Phase

Demonstrate the feasibility of performing bQUS analysis on ultrasound echo signals acquired of the fetal lung

Single visit (up to 30 minutes)
1 visit (in-person)

Hypothesis-Testing Phase

Estimate the populational variance of the quantitative features from bQUS applied to ultrasound data

Single visit (up to 30 minutes)
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Backscatter Quantitative Ultrasound

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: 36 Weeks PregnantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Citations

Correlation between lung maturity and backscatter ...

As a proof of concept, we show that quantitative medical ultrasound can provide information on fetal lung maturity accurately. (1) M. S. ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32653881/

Assessment of Fetal Lung Maturity Using Quantitative ...

This study demonstrates a good accuracy of QuantusFLM® as a NRM predictor in patients with PROM, with particular reliability in identifying ...

A Robustness Study Using Fetal Lung Ultrasound Images

The results showed that quantitative US of fetal lung texture predicted neonatal respiratory morbidity with a sensitivity, specificity ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37097317/

Prediction of lung maturity through quantitative ultrasound ...

QuantusFLM software was able to predict lung maturity in diabetes group with 96.4 % accuracy, 96.4 % sensitivity and 100 % positive predictive value.

uitc 2025 abstracts

The objective of this research is to explore the use of convolutional neural networks (CNNs) for assessing fetal lung maturity in ultrasound images. The CNN in ...

Characterization of Fetal Lung With Quantitative Ultrasound

The purpose of the study is to show if it's possible to use a special kind of ultrasound called backscatter quantitative ultrasound (bQUS) to check on a baby's ...

Characterization of Fetal Lung With Quantitative - ClinConnect

This clinical trial is investigating a new way to check a baby's lungs using a special ultrasound technique called backscatter quantitative ultrasound (bQUS).

Artificial Intelligence in Quantitative Ultrasound Imaging: A ...

Quantitative ultrasound (QUS) imaging is a safe, reliable, inexpensive, and real-time technique to extract physically descriptive parameters ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24919442/

Quantitative ultrasound texture analysis of fetal lungs to ...

A novel method for predicting neonatal respiratory morbidity based on quantitative analysis of the fetal lung by ultrasound.