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Parenteral Nutrition

Phase 3

Malnutrition | Small molecule | Metabolic |Pediatrix Medical Group, Inc.|Last Updated: Sep 28, 2006

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical trial landscape

Parenteral Nutrition · 1 trial · 1 indication

Phase 3 1
NCT00120926Dose Comparison of Amino Acids on Growth in Premature NeonatesMalnutrition
COMPLETED150 Analytics
PHASE3COMPLETED
Dose Comparison of Amino Acids on Growth in Premature Neonates
Malnutrition
NCT00120926150
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Study Endpoints
Primary Endpoints
The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length
Secondary Endpoints
Secondary outcomes include serum amino acid profiles measured on: day 7 of life, day 28 of life
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Parenteral NutritionDRUG -
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Eligibility Criteria
Age Range0 Years to 48 Hours
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Documentation of informed consent * Inborn * Gestational age between 23 weeks and 0/7 days and 29 weeks and 6/7 days * If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes * No major anomalies * Ability to begin parenteral nutrition w...

Countries:United States
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