Идёт набор NCT06722365

Characterization of Fetal Lung With Quantitative Ultrasound

— Наблюдательное Respiratory Complication Fetal Lung Imaging

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Backscatter Quantitative Ultrasound.
Кому может быть актуально: Состояния в реестре: Respiratory Complication, Fetal Lung Imaging. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Устройство 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

Первичные конечные точки

Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data [Срок оценки: data collected over a single study visit (up to 30 minutes)]

Вторичные конечные точки (1)

Population Variance in Fetal Lung Microstructure [Срок оценки: data collected over a single study visit (up to 30 minutes)]

Критерии участия

Критерии включения

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.