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Parenteral Nutrition

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00120926Dose Comparison of Amino Acids on Growth in Premature NeonatesPHASE3 COMPLETED 150 — — Aug 1, 2005Jun 1, 2006Sep 28, 20061 United States
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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 — 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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