Clinical trial NCT06722365: Characterization of Fetal Lung With Quantitative Ultrasound
Official title: Characterization of Fetal Lung With Quantitative Ultrasound
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Complication
Fetal Lung Imaging
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data
timeFrame: data collected over a single study visit (up to 30 minutes)
Secondary outcomes:
measure: Population Variance in Fetal Lung Microstructure
timeFrame: data collected over a single study visit (up to 30 minutes)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Meriter Hospital
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: J. Igor Iruretagoyena, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: