Trial · NCT02579265
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample | Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl | The numbers in the subgroups refer to 100% | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Body Weight (Change From Baseline) | Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up) | The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Body Length (Change From Baseline) | Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up | The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Head Circumference (Change From Baseline) | Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-up | The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Full Enteral or Oral Feeds | Day 29/end of treatment, if continued: Day 85/end of treatment | The Standard Deviation for Time to Event was not calculated. NA=Not available | Time to event in days | MEDIAN |
| SECONDARY | Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline) | Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment | Over time analysis of laboratory parameters were assessed at all timepoints as available | ug/mL | MEAN |
| SECONDARY | Length of Stay in Hospital | Day 1- Follow up (7 days after end of treatment) | Median time (days) until discharge | MEDIAN | |
| SECONDARY | Ratio of Independent Bloodstream Infections to Number of Days on Study Medication | Day 1-29 or -85 if continued + Follow-up | ratio | MEAN | |
| SECONDARY | Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication | Day 1-29 or -85 if continued + Follow-up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Who Complete PN Treatment Without Lipid Minimization | Day 1-29 or -85 if continued + Follow-up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels | Day 1-29 or -85 if continued + Follow-up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study | Day 1-29 or -85 if continued + Follow-up | Missing | mg/dl*days | MEAN |
| SECONDARY | Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization | Day 1-29 or -85 if continued + Follow-up | Missing | Cumulative days | MEAN |
| SECONDARY | Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First) | Day 1-29 or -85 if continued + Follow-up | NA=Not available Since the number of events was not sufficient, no further analysis was performed. | Number of days | MEAN |
| SECONDARY | Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol) | Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment | Over time analysis of laboratory parameters were assessed at all timepoints as available. Timepoints \>10% of Subjects (overall) are displayed. | ug/mL | MEAN |
| SECONDARY | Holman Index | Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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