Meriter Hospital
Madison, Wisconsin, 53715, United States
Location status: Recruiting
NCT Number: NCT06722365
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.
Interested in participating?
Request Info18 year–45 year
Female
Observational
Madison, Wisconsin, 53715, United States
Location status: Recruiting
Primary Objective:
Secondary Objectives:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Ultrasound, bQUS
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05856136
Respiratory Complication, Respiratory Function Loss
Rochester, Minnesota, United States
View Trial DetailsNCT06412081
Respiratory Complication
Brussels, Brussels Capital, Belgium
View Trial DetailsNCT04959526
Respiratory Complication, Respiratory Function Loss
Rochester, Minnesota, United States
View Trial DetailsNCT06719258
Humidifier Lung, Mechanical Fragility
Québec, Quebec, Canada
View Trial Details