Detailed Result for NCT01096446
NCT ID: | NCT01096446 |
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NLM Download Date Description: | N/A |
Study First Submitted Date: | 2010-03-30 |
Last Update Submitted Date: | 2014-11-19 |
Last Update Submitted Date: | 2014-11-19 |
Result First Submitted Date: | 2013-11-25 |
Disposition First Submitted Date: | N/A |
Start Month Year: | April 2008 |
Start Date: | 2008-04-30 |
Start Date Type: | N/A |
Verification Month Year: | November 2014 |
Verification Date: | 2014-11-30 |
Completion Month Year: | July 2010 |
Completion Date: | 2010-07-31 |
Completion Date Type: | Actual |
Primary Completion Month Year: | May 2010 |
Primary Completion Date: | 2010-05-31 |
Primary Completion Date Type: | Actual |
Study first Submitted QC Date: | 2010-03-30 |
Study first posted Date: | 2010-03-31 |
Result first Submitted QC Date: | 2014-11-19 |
Result First Posted Date: | 2014-11-20 |
Disposition First Submitted QC Date: | N/A |
Disposition First Posted Date: | N/A |
Last Updated Submitted QC Date: | 2014-11-19 |
Last Updated Posted Date: | 2014-11-20 |
Target Duration: | N/A |
Study Type: | Interventional |
Acronym: | N/A |
Baseline Population: | Twelve infants were randomized into the experimental arm and 10 infants were randomized into the control arm. |
Brief Title: | Intravenous Fat Emulsions and Premature Infants |
Official Title: | Tolerance of Higher Infusion Rates of Intravenous Fat Emulsions in Extremely Low Birthweight Infants During the First Week of Life |
Overall Status: | Terminated |
Last Known Status: | N/A |
Phase: | Not Applicable |
Enrollment: | 19 |
Enrollment Type: | Actual |
Source: | OSF Healthcare System |
Limitation and Caveats: | N/A |
Number of Arms: | 2 |
Number of Groups: | N/A |
Why Stopped: | To many infants in the experimental group developed hypertriglyceridemia |
Has Expanded Access: | N/A |
Expanded Access Type Individual: | N/A |
Expanded Access Type Intermediate: | N/A |
Expanded Access Type Treatment: | N/A |
Has DMC: | true |
Is it FDA Regulated Drug: | N/A |
Is it FDA Regulated Device: | N/A |
Is it Unapproved Device: | N/A |
Is PPSD: | N/A |
Is US Export: | N/A |
Is Biospec Retention: | N/A |
Biospec Description: | N/A |
Plan to Share IPD: | N/A |
Plan to Share IPD Description: | N/A |
IPD Time Frame: | N/A |
IPD Access Criteria: | N/A |
IPD URL: | N/A |