Use of Oxandrolone to Promote Growth in Infants With HLHS

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthCore-NERI; New England Research Institutes
• Treatments: Oxandrolone

Criteria

Inclusion Criteria:

1. HLHS and other single ventricle of right ventricular morphology

2. Age and Norwood procedure ≤14 days of age

3. Informed consent from parent/guardian

Exclusion Criteria:

1. Small for gestational age (birth weight <10th percentile for gestational age)

2. Prematurity, defined as gestational age <37 weeks

3. Intrauterine growth retardation (birth weight ≤2.5 kg and gestational age ≥38 weeks)

4. Chromosomal abnormality, recognizable genetic syndrome or congenital anomalies of more than minor severity associated with growth failure

5. Moderate or greater right ventricular systolic dysfunction and/or moderate or greater tricuspid regurgitation prior to the Norwood procedure

6. Extracorporeal membrane oxygenation support (ECMO) prior to or within 24 hours of Norwood procedure

7. Pre-Norwood interventions (fetal intervention, balloon atrial septostomy for an intact or restrictive atrial septum)

8. Pre-Norwood pulmonary venous obstruction

9. Pre-Norwood procedure necrotizing enterocolitis and/or other gastrointestinal syndromes

10. Known contraindication to oxandrolone

11. Planned or current warfarin therapy at screening (warfarin effects are increased by anabolic drugs)

12. Significant hepatic dysfunction (elevation of serum transaminase levels greater than two times the upper limit of normal local laboratory standard at screening)

13. Hypercalcemia (>1.5 times upper normal range for lab)

14. Nephrotic syndrome

15. Unwillingness or inability to return to surgical center for follow-up evaluation

16. Participation in another clinical study that may impact growth