Use of Oxandrolone to Promote Growth in Infants With HLHS

Stopped early · Phase 1/Phase 2

Conditions studied: Hypoplastic Left Heart, Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT04090697

Run by

Carelon Research

People needed

34

Starts

2019-12-20

Expected to finish

2023-09-19

Last updated by the study team

2024-05-23

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HLHS and other single ventricle of right ventricular morphology
• Age and Norwood procedure ≤14 days of age
• Informed consent from parent/guardian

You may not qualify if…

• Small for gestational age (birth weight <10th percentile for gestational age)
• Prematurity, defined as gestational age <37 weeks
• Intrauterine growth retardation (birth weight ≤2.5 kg and gestational age ≥38 weeks)
• Chromosomal abnormality, recognizable genetic syndrome or congenital anomalies of more than minor severity associated with growth failure
• Moderate or greater right ventricular systolic dysfunction and/or moderate or greater tricuspid regurgitation prior to the Norwood procedure
• Extracorporeal membrane oxygenation support (ECMO) prior to or within 24 hours of Norwood procedure
• Pre-Norwood interventions (fetal intervention, balloon atrial septostomy for an intact or restrictive atrial septum)
• Pre-Norwood pulmonary venous obstruction
• Pre-Norwood procedure necrotizing enterocolitis and/or other gastrointestinal syndromes
• Known contraindication to oxandrolone
• Planned or current warfarin therapy at screening (warfarin effects are increased by anabolic drugs)
• Significant hepatic dysfunction (elevation of serum transaminase levels greater than two times the upper limit of normal local laboratory standard at screening)
• Hypercalcemia (>1.5 times upper normal range for lab)
• Nephrotic syndrome
• Unwillingness or inability to return to surgical center for follow-up evaluation
• Participation in another clinical study that may impact growth

Where it is running

• 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
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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