drugset / Trial / NCT04090697
Use of Oxandrolone to Promote Growth in Infants With HLHS
RandomizedParallel-groupOpen-labelSupportive care
Summary
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.
Timeline
- Start
- 2019-12-20
- Primary completion
- 2023-09-19
- Completion
- 2023-09-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxandrolone | Small molecule | 0.1 mg/kg | Other |
| Subject | Oxandrolone | Small molecule | 0.15 mg/kg | Other |