Clinical trialNCT04090697TerminatedPhase 1/PHASE2Interventional

Use of Oxandrolone to Promote Growth in Infants With HLHS

SponsorCarelon ResearchEnrollment34Congenital Heart DiseaseHypoplastic Left Heart

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The primary aim of this study is to determine if clinically relevant doses of buccally administered oxandrolone are safe and tolerable in neonates with hypoplastic left heart syndrome (HLHS) or other single right ventricular anomalies who have undergone a Norwood procedure. The secondary aim is to evaluate the efficacy of buccally administered oxandrolone in improving objective indices of growth and nutrition in neonates who have undergone a Norwood procedure.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Phillip T Burch, MD
University of Mississippi Medical Center
Principal Investigator
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Richard V Williams, MD
University of Utah
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

the Hospital for Sick Children
Toronto, Ontario, Canada

United States

Children'S Hospital of Atlanta
Atlanta, Georgia, United States
Boston Children'S Hospital
Boston, Massachusetts, United States
University of Michigan Health System, Ann Arbor
Ann Arbor, Michigan, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Cook Children'S Medical Center
Fort Worth, Texas, United States
Texas Children'S Hospital
Houston, Texas, United States
Primary Children'S Medical Center
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Oxandrolone →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 20 Dec 2019
Primary completion: 19 Sept 2023
Completion: 19 Sept 2023
Last update posted: 23 May 2024
Registered enrollment: 34
Registry id: NCT04090697

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.