drugset / Trial / NCT02476994

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

NCT02476994 ↗

Phase 4 Terminated 1 enrolled Baxter Healthcare Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.

Timeline

Start
2015-05
Primary completion
2016-10
Completion
2016-10

Outcome

Outcome not reported

Stopped: “Based on feedback from FDA”

Drugs

EvaluationDrugModalityDoseRoute
Subject Clinolipid Other / unclassified 20 % —
Comparator Intralipid Other / unclassified 20 % —

Indications