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NCT05767385 · ClinicalTrials.gov registry record · Phase 2

Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior

A Phase 2 study of Hypoxia and Neurodevelopmental Disorders, sponsored by University of Utah.

Recruiting
Registry status
Phase 2
Development phase
150
Enrollment target
5
Study locations

NCT05767385 is a Phase 2 study of Hypoxia and Neurodevelopmental Disorders that is actively recruiting participants, run by University of Utah. The registered enrollment target is 150 participants, below the 3,113-participant average among 39 other Hypoxia trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT05767385, a Phase 2 study of Hypoxia and Neurodevelopmental Disorders, is actively recruiting participants, sponsored by University of Utah.

RECRUITING
Registry status
Phase 2
Development phase
150 participants
Enrollment target
5
Study locations

Study Summary

Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design. Pregnant women will be approached during one of their fetal cardiology clinic visits.

Interventions

  • PROCEDURE Single Arm
  • PROCEDURE Neonatal Neurobehavioral Scale

Study Locations (5)

Utah

  • Primary Children's Hospital - Salt Lake City
  • University of Utah - Salt Lake City

California

  • University of California San Francisco - San Francisco

District of Columbia

  • Children's National Medical Center - Washington D.C.

Maine

  • Maine Medical Center - Scarborough

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2021-12-17
Est. Completion 2025-12
Phase Phase 2

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT05767385

The ClinicalTrials.gov registry entry for NCT05767385 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,113-participant average among 39 other Hypoxia trials with a reported enrollment target (95% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Hypoxia appearing as the primary indexed condition, and to 2 interventions - of which Single Arm is the first listed.

NCT05767385 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Utah, California, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT05767385 about?

NCT05767385 is a clinical study titled "Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior". Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants o...

What is the current status of trial NCT05767385?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2021-12-17. Estimated completion is 2025-12.

What conditions does trial NCT05767385 study?

This clinical trial studies the following conditions: Hypoxia, Neurodevelopmental Disorders, Congenital Heart Disease in Children, Complex Congenital Heart Disease.

What interventions are being tested in trial NCT05767385?

The interventions under investigation include: Single Arm (PROCEDURE), Neonatal Neurobehavioral Scale (PROCEDURE).

Who is sponsoring clinical trial NCT05767385?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05767385 being conducted?

This trial has 5 study locations across California, District of Columbia, Maine, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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