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RECRUITING Phase 2

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

NCT05767385 · View on ClinicalTrials.gov ↗

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

686 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05767385

The ClinicalTrials.gov registry entry for NCT05767385 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 686 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05767385 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Utah, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05767385?

The interventions under investigation include: Single Arm (PROCEDURE), Neonatal Neurobehavioral Scale (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05767385?

This trial is sponsored by University of Utah, which has 686 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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