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ACTIVE NOT RECRUITING Phase 3

Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT

NCT04702373 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.

Conditions Studied

Interventions

  • OTHER passive range of motion exercise therapy

Study Locations (10)

Georgia

  • Children's Healthcare of Atlanta / Emory University — Atlanta

Indiana

  • Riley Children's Hospital of Indiana — Indianapolis

Massachusetts

  • Boston Children's Hospital — Boston

Michigan

  • University of Michigan — Ann Arbor

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia

South Carolina

  • Medical University of South Carolina — Charleston

Texas

  • Texas Children's Hospital / Baylor — Houston

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2021-02-23
Est. Completion 2024-12-30
Phase Phase 3

Sponsor

Carelon Research

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04702373

The ClinicalTrials.gov registry entry for NCT04702373 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention — of which passive range of motion exercise therapy 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: NCT04702373 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Georgia, Indiana, Massachusetts. 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 NCT04702373 about?

NCT04702373 is a clinical study titled "Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT". This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.

What is the current status of trial NCT04702373?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2021-02-23. Estimated completion is 2024-12-30.

What conditions does trial NCT04702373 study?

This clinical trial studies the following conditions: 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 NCT04702373?

The interventions under investigation include: passive range of motion exercise therapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04702373?

This trial is sponsored by Carelon Research, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04702373 being conducted?

This trial has 10 study locations across Georgia, Indiana, Massachusetts, Michigan, Ohio. 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