deltatrials
Terminated NA INTERVENTIONAL 2-arm NCT01096446

Intravenous Fat Emulsions and Premature Infants

Tolerance of Higher Infusion Rates of Intravenous Fat Emulsions in Extremely Low Birthweight Infants During the First Week of Life

Sponsor: OSF Healthcare System

Updated 6 times since 2017 Last updated: Nov 19, 2014 Started: Apr 30, 2008 Primary completion: May 31, 2010 Completion: Jul 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

To many infants in the experimental group developed hypertriglyceridemia

This NA trial investigates Hyperglycemia and Hypertriglyceridemia and is currently terminated or withdrawn. OSF Healthcare System leads this study, which shows 6 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

ELBW infants will be randomized into either the control group or the experimental group. The control group will receive standardized care which consists of receiving TPN within 24 to 36 hours of life. The control group will be given the standardized dosage of IVFE starting at 0.5 grams/kg/day in the TPN and have IVFE advanced daily by 0.5 grams/kg/day until a goal rate of 3 grams/kg/day is achieved. The experimental group will receive TPN within 24 to 36 hours of life. For these infants, IVFE will begin at 2 grams/kg/day. For the experimental group, Intralipid will be increased by 0.5 grams/kg/day until a goal rate of 3 grams/kg/day is achieved. An informed consent form (Appendix A), to be signed by the parent or guardian, will be obtained for all infants before they are enrolled into this study. Assent waiver is requested on the study participants because they are infants. All infants enrolled in this study will have their laboratory data monitored at least daily during the first week of life. A baseline triglyceride will be drawn prior to beginning TPN to verify that their serum triglyceride levels are \<200 gm/dl. This will include a daily lipid profile panel used to...

ELBW infants will be randomized into either the control group or the experimental group.

The control group will receive standardized care which consists of receiving TPN within 24 to 36 hours of life. The control group will be given the standardized dosage of IVFE starting at 0.5 grams/kg/day in the TPN and have IVFE advanced daily by 0.5 grams/kg/day until a goal rate of 3 grams/kg/day is achieved. The experimental group will receive TPN within 24 to 36 hours of life. For these infants, IVFE will begin at 2 grams/kg/day. For the experimental group, Intralipid will be increased by 0.5 grams/kg/day until a goal rate of 3 grams/kg/day is achieved.

An informed consent form (Appendix A), to be signed by the parent or guardian, will be obtained for all infants before they are enrolled into this study. Assent waiver is requested on the study participants because they are infants.

All infants enrolled in this study will have their laboratory data monitored at least daily during the first week of life. A baseline triglyceride will be drawn prior to beginning TPN to verify that their serum triglyceride levels are \<200 gm/dl. This will include a daily lipid profile panel used to evaluate the serum triglyceride levels and the tolerance of the two different IVFE infusion rates. Lipid tolerance will be defined as infants having a serum triglyceride levels at \< 200 mg/dl. Lipid intolerance will be defined as infants having a serum triglyceride of 201 mg/dl or greater. If lipid intolerance occurs, IVFE will be decreased by the following standard of care:

Serum Triglycerides Levels Changes Intralipid in TPN by:

150-200 mg/dl Keep at current IVFE order 201-249 mg/dl decrease by 1 grams/kg/day 250-299 mg/dl decrease by 1.5 gram/kg/day 300 mg/dl or greater Reduce Intralipid to 0.5 grams/kg/day to prevent essential fatty acid deficiency (EFAD). If hypertriglyceridemia persists (300 mg/dlor greater) over 24 hours keep IVFE at 0.5 gm/kg/day to prevent EFAD.

The total caloric intake will be calculated and collected daily for both groups. The calorie intake will be specified as total kilocalories per kilogram (kcal/kg/day). The goal calorie intake for both groups will be 90 kcal/kg/day. The kcal/kg index will be calculated by a Registered Dietitian, who is assigned to the Neonatal Intensive Care Unit.

All collected data will be presented as a mean +/- SD. The statistical significance will be defined by a p value \< 0.05.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated NA

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated NA

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated NA

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated NA

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated NA

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Terminated NA

    First recorded

Apr 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • OSF Healthcare System
Data source: OSF Healthcare System

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations