Trial · NCT02579265
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation. |
| Secondary | Body Weight (Change From Baseline) | Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up) | Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007). |
| 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 | Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007). |
| 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 | Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007). |
| Secondary | Time to Full Enteral or Oral Feeds | Day 29/end of treatment, if continued: Day 85/end of treatment | Time to full enteral or oral feeds (i.e. PN weaning) is the time from the randomization date to the date of the first full enteral or oral Feeds. |
| 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 | RBC refers to red blood cells. Timepoints \>10% of Subjects (overall) are displayed. |
| Secondary | Length of Stay in Hospital | Day 1- Follow up (7 days after end of treatment) | Length of stay in hospital (time from randomization to discharge) was be calculated. NA=Not available |
| Secondary | Ratio of Independent Bloodstream Infections to Number of Days on Study Medication | Day 1-29 or -85 if continued + Follow-up | The Ratio is the incidence of bloodstream infection by numbers of day on study medication. |
| 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 | |
| Secondary | Number of Patients Who Complete PN Treatment Without Lipid Minimization | Day 1-29 or -85 if continued + Follow-up | The Analysis was conducted over all study phases. |
| 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 | |
| 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 | The area under the curve (AUC\>1.5) is defined as the area between conjugated bilirubin concentrations \> 1.5 mg/dL and the horizontal line at 1.5 mg/dL, restricted by the time point of study withdrawal, if applicable. Analysis displays the summary of Area Under the Curve of Bilirubin Levels for the Time Period in Which Conjugated are \>1.5 mg/dL |
| Secondary | Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization | Day 1-29 or -85 if continued + Follow-up | The Analysis was performed over the entire study period. |
| 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 | |
| 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 | |
| Secondary | Holman Index | Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatment | Essential fatty acid deficiency is based on the ratio of Mead acid and Arachidonic acid (also called the triene/tetraene ratio or Holman index; Holman, 1960). A ratio of \> 0.2 was considered abnormal (=essential fatty acid deficiency; Holman et al., 1979). Timepoints with \>10% of patients are displayed. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02579265/registered