Characterization of Fetal Lung With Quantitative Ultrasound

Recruiting

• Conditions: Respiratory Complication; Fetal Lung Imaging

• Registration Number: NCT06722365
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-09
• Study Start: 2024-12-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data	data collected over a single study visit (up to 30 minutes)	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 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.

Secondary Outcome Measures

Name	Time	Method
Population Variance in Fetal Lung Microstructure	data collected over a single study visit (up to 30 minutes)	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.

Trial Locations

Locations (1)

Meriter Hospital; 🇺🇸 Madison, Wisconsin, United States