At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 40 enrolled
Drug / intervention
intravenous lipiddrug
Likely dose
Intravenous lipid administered daily for 6 weeksAI-extracted
Key inclusion· 3
- ✓Gestational age ≥34 weeks
- ✓Major GI surgical disorders requiring surgery: Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, or GI perforations
- ✓Admitted to NICU within first 72 hours
Key exclusion· 5
- ✕Does not require TPN by 72 hours of life
- ✕Direct hyperbilirubinemia within first 72 hours after birth
- ✕TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc)
- ✕Biliary tract disorders leading to direct hyperbilirubinemia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.
In Brief
A Phase 3 clinical trial evaluating intravenous lipid for Parenteral Nutrition Associated Cholestasis. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedMar 2012
Primary CompletionOct 2018
Study CompletionJan 2019
TodayJul 2026
First PostedMar 16, 2012
Enrollment StartFeb 1, 2012
Primary CompletionOct 30, 2018
Study CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 14.3 years ago
Interventions
intravenous lipiddrug
intravenous given daily for 6 weeks