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Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants

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ClinicalTrials.gov Identifier: NCT01048632
Recruitment Status : Unknown
Verified January 2017 by Phillip Burch, University of Utah.
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2010
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Phillip Burch, University of Utah

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malnutrition Drug: Oxandrolone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants After Cardiac Surgery
Study Start Date : July 2010
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Oxandrolone

Arm Intervention/treatment
Experimental: Oxandrolone
Following clinical evaluation, all patients will be receive oxandrolone in addition to their usual medications. Based upon the patient's body weight, the coordinator, PI or sub-PI will determine the appropriate dose of oxandrolone (0.1 mg/kg/dose twice daily via the buccal mucosa.)
Drug: Oxandrolone
2.5 mg oxandrolone tablets.Based upon the patient's body weight, the coordinator, PI or sub-PI will determine the appropriate dose of oxandrolone (0.1 mg/kg/dose twice daily via the buccal mucosa.)




Primary Outcome Measures :
  1. PK testing [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Measures of Severity of Malnutrition to include pre albumin, C-reactive protein, nitrogen balance and measurements of somatic growth. [ Time Frame: Measurements: Baseline, Day #1, Day #7, Day #14, Day #21, Day #28 ]


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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048632


Locations
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United States, Utah
Primary Childrens Hospital
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Phillip T Burch, MD University of Utah Dept. of Surgery-Div Cardiothoracic surgery

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Responsible Party: Phillip Burch, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01048632     History of Changes
Other Study ID Numbers: IRB 41510
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Phillip Burch, University of Utah:
Neonates with HLHS or variant with plan to undergo Norwood Procedure
Additional relevant MeSH terms:
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Malnutrition
Infant Nutrition Disorders
Nutrition Disorders
Oxandrolone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents