Malnutrition Clinical Trial
Official title:
A Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants After Cardiac Surgery
NCT number | NCT01048632 |
Other study ID # | 41510 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 2010 |
Est. completion date | May 2016 |
Verified date | January 2020 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 therapy has not been
previously implemented in neonates thus we 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 by collecting anthropometric measurements
and pharmacokinetic data.
Neonates with HLHS or variant with planned Norwood Procedure. The primary aims of this pilot
study are to assess safety and efficacy of oxandrolone in this population. Our goal will be
to enroll 5 patients in each phase of this pilot study. The incidence of adverse events will
also be monitored and compared to untreated patients. Enrollment will continue until the
target of 20 total patients has been met.
Status | Completed |
Enrollment | 20 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Month |
Eligibility |
Inclusion Criteria: - Neonates with HLHS, with plan to undergo the Norwood Procedures Exclusion Criteria: - Neonates with a birth weight =2.5 kg and gestational age =38 weeks (indicating intrauterine growth retardation), gestational age < 35 weeks (premature infants), and/or chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (e.g. Trisomy 21, Trisomy 13, Noonan's syndrome, Turner's syndrome) will be excluded from enrollment. Neonates who will not be placed on the high risk feeding protocol postoperatively will also be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Primary Childrens Hospital | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PK testing | 48 hours | ||
Secondary | Measures of Severity of Malnutrition to include pre albumin, C-reactive protein, nitrogen balance and measurements of somatic growth. | Measurements: Baseline, Day #1, Day #7, Day #14, Day #21, Day #28 |
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