Track topics on Twitter Track topics that are important to you
Oxandrolone is an anabolic steroid, marketed in the United States as an adjunctive therapy to combat weight loss resulting from chronic infection, extensive surgery, severe trauma, protein catabolism associated with prolonged administration of corticosteroids, and for the relief of bone pain accompanying osteoporosis. In children, it has been used to prevent and treat growth failure associated with severe burns (≥ 40% of total body surface area), Duchenne muscular dystrophy, Turner's syndrome, constitutional delay of growth and puberty, and chronic wasting in HIV-positive pediatric patients. Other applications in children have included treatment of central idiopathic precocious puberty, hereditary angioedema, and bilateral congenital anorchia. Growth failure is a common feature of infants with complex congenital heart disease, and can adversely affect outcome. This randomized, double-blind, placebo-controlled trial will evaluate the safety and efficacy of administering oxandrolone to improve growth in neonates with complex congenital heart disease who have undergone surgical palliation or repair.
Neonates with a RACHS-1 (risk adjustment in congenital heart surgery method) score of ≥4 will be eligible for enrollment. Neonates will be randomly assigned to receive oxandrolone or placebo and then followed for 28 days. Nutritional data will be collected at five time points. The primary aims of this pilot study are to assess safety and efficacy of oxandrolone in this population. Our goal will be to enroll 10 patients in each arm of this pilot study. The incidence of adverse events will also be compared between the treatment groups. Enrollment will continue until the target of 10 patients in each arm has been met.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary Children's Medical Center
Salt Lake City
Not yet recruiting
University of Utah
Published on BioPortfolio: 2014-07-23T21:11:08-0400
RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megest...
The purpose of the program is to study and characterize the outcome of burn injury with particular attention to improving the rehabilitation of burn survivors, including children. Various ...
To assess the pharmacokinetics and relative bioavailability of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a small...
Malnutrition is common problem in hospitalized geriatrics at discharge. Malnutrition is a high risk for functional limitations, impaired muscle strength and reduced quality of life.
The purpose of this study is to determine the effect of oxandrolone on the function and quality of life of patients with chronic spinal cord injury.
Effectiveness of the Malnutrition Quality Improvement Initiative on Practitioner Malnutrition Knowledge and Screening, Diagnosis, and Timeliness of Malnutrition-Related Care Provided to Older Adults Admitted to a Tertiary Care Facility: A Pilot Study.
Malnutrition is present in 30% to 50% of hospitalized patients aged 60 years or older. As few as 3.2% of patients identified as high risk have a malnutrition diagnosis documented by medical providers....
Malnutrition is associated with many adverse clinical outcomes. The present study aimed to identify the prevalence of malnutrition in hospitalized patients in Korea, evaluate the association between m...
Malnutrition is a condition most commonly arising from the inadequate consumption of nutrients necessary to maintain physiological health and is associated with the development of cardiovascular disea...
The term malnutrition generally refers to both under-nutrition and over-nutrition, but this study uses the term to refer solely to a deficiency of nutrition. In Ethiopia, child malnutrition is one of ...
Malnutrition is highly prevalent in geriatric patients and is associated with an increased risk of death. In addition, delirium is a common condition of the older hospitalized patients. As brain has a...
A synthetic hormone with anabolic and androgenic properties.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Acute form of MALNUTRITION which usually affects children, characterized by a very low weight for height (below -3z scores of the median World Health Organization standards), visible severe wasting, or occurrence of nutritional EDEMA. It can be a direct or indirect cause of fatality in children suffering from DIARRHEA and PNEUMONIA. Do not confuse with starvation, a condition in which the body is not getting enough food, usually for extended periods of time.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
General ill health, malnutrition, and weight loss, usually associated with chronic disease.
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...