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 lungs when the mother is 36 weeks pregnant. 16 participants will be on study for a single 30 minute ultrasound between 32 and 36 weeks of pregnancy.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Complication; Fetal Lung Imaging
• Intervention / Treatment: Device: Backscatter Quantitative Ultrasound

Detailed Description

Primary Objective:

• Demonstrate the feasibility of performing bQUS analysis on ultrasound echo signals acquired of the fetal lung acquired with clinical ultrasound scanners during third -trimester ultrasound scans

Secondary Objectives:

• Design and implement a protocol to acquire non-processed (raw) echo signals from a commercial ultrasound scanner necessary to perform bQUS at the UPH-Meriter Center for Perinatal Care (CPC).
• Quantify the populational variance of quantitative features extracted from bQUS applied to ultrasound data collected from third trimester ultrasound scans of the fetal lung.

The study will be divided into two phases: (i) feasibility phase and (2) hypothesis-testing phase recruitment phase. Phase 1 will provide evidence of the technical viability of data acquisition at UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 16 participants to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.

• Study Type: Observational
• Enrollment (Estimated): 16

Contacts and Locations

• Study Contact: Name: UW Ob/Gyn Human Subjects Core; Phone Number: 608-890-3345; Email: research.crc_obgyn@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Recruiting
      • Meriter Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant females ages 18 to 45 years old with singleton pregnancy, live fetus, gestational age between 32.1 and 36.7 weeks, not in labor, scheduled for routine ultrasound growth evaluation

Description

Inclusion Criteria:

• Pregnant females ages 18 to 45 years old with singleton pregnancy, live fetus, gestational age between 32.1 and 36.7 weeks, not in labor, scheduled for routine ultrasound growth evaluation.
• Gestational age determined by the date of the last menses, and confirmed by measurement of the crown-rump-length on transabdominal ultrasound.

Exclusion Criteria:

• Subjects unable to consent
• Active Labor
• Fetal malformations of the lungs
• Prescription of corticosteroids prior to ultrasound evaluation
• Pre-gestation or gestational diabetes mellitus
• Low English proficiency, needing an interpreter

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

36 Weeks Pregnant

Device: Backscatter Quantitative Ultrasound; The intervention consists of a regular abdominal ultrasound scan for fetal evaluation. The difference with a regular scan is that the scanner used to image the fetus provides access to raw/unprocessed ultrasound echo data that can be extracted from the scanner and processed offline (after acquisition) to extract compute backscatter quantitative ultrasound (bQUS) features. Thus, data acquisition does not represent a significant departure from conventional fetal imaging protocols. Other than the time needed to acquire the images, the participant will not perceive any difference from a regular fetal ultrasound scan.; Other Names: Ultrasound; bQUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data	Phase 1 will provide evidence of the technical viability of data acquisition at the UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 16 participants to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.	data collected over a single study visit (up to 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Population Variance in Fetal Lung Microstructure	Populational variance σ^2_Pop: variance of the individual participant median value of a quantitative ultrasound feature q_(M,s) obtained from the N_S participants included in the analysis.	data collected over a single study visit (up to 30 minutes)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: J. Igor Iruretagoyena, MD, MS, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 2024-0634; A532860 (Other Identifier: UW Madison); Protocol Version 3/4/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing with external collaborators will be provided through FlyWheel Exchange.
• IPD Sharing Time Frame: Coded data and the linking files will be stored for 7 years after conclusion of the study. After seven years, linking files and codes will be destroyed, and the de-identified data will be stored indefinitely for potential future research use.
• IPD Sharing Access Criteria: Permission to access data will be provided within Data Sharing Agreements and only after IRB approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes