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Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

NCT01050660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2014-10-28

Study results available
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Summary

The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.

Conditions

  • Parenteral Nutrition-Associated Liver Disease

Interventions

OTHER

Intravenous fat emulsion

An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.

OTHER

Restriction of intravenous fat emulsion to 1 gm/kg/d

Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.

Sponsors & Collaborators

Principal Investigators

  • Richard A Ehrenkranz, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-11-30
Completion
2013-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01050660 on ClinicalTrials.gov