Characterization of Fetal Lung With Quantitative Ultrasound

NCT ID: NCT06722365

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-17
• Study Completion Date: 2026-06-30

Brief Summary

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. 12 participants will be on study for a single 30 minute ultrasound between 32 and 36 weeks of pregnancy.

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 12 subjects to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.

Conditions

Respiratory Complication; Fetal Lung Imaging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

36 Weeks Pregnant

Backscatter Quantitative Ultrasound

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Ultrasound; bQUS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Igor Iruretagoyena, MD, MS

Role: PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Locations

Meriter Hospital

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

UW Ob/Gyn Human Subjects Core

Role: CONTACT

research.crc_obgyn@wisc.edu

608-890-3345

Other Identifiers

Protocol Version 1/24/25

Identifier Type: OTHER

Identifier Source: secondary_id

A532860

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0634

Identifier Type: -

Identifier Source: org_study_id