Characterization of Fetal Lung With Quantitative Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Backscatter Quantitative Ultrasound.
- Who it may be relevant to
- Registry conditions: Respiratory Complication, Fetal Lung Imaging. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- 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 t
Primary outcome measures
- Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data [Time frame: data collected over a single study visit (up to 30 minutes)]
Secondary outcome measures (1)
- Population Variance in Fetal Lung Microstructure [Time frame: data collected over a single study visit (up to 30 minutes)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Meriter Hospital — Madison
Identifiers
NCT: NCT06722365 · 2024-0634 · Protocol Version 3/4/25 · A532860