Fetal Lung Imaging, Respiratory Complication
Conditions
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. 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
DEVICEBackscatter 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.
Sponsors
University of Wisconsin, Madison
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTUW Ob/Gyn Human Subjects Core
PRINCIPAL_INVESTIGATORJ. Igor Iruretagoyena, MD, MS
UW School of Medicine and Public Health
Outcome results
None listed