Trial · NCT00738101
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
NCT00738101, Not applicable, Completed, Baylor College of Medicine; results first posted 2020-05-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants. Trials, record NCT00738101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00738101
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
- NCT number
- NCT00738101
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 293 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Cholestasis, Cholestasis of Parenteral Nutrition
- Interventions
- Omegaven
- First posted
- 2008-08-20
- Last updated
- 2021-05-28
- Results first posted
- 2020-05-21
- Limitations and caveats
- The study protocol was terminated early following the FDA approval of the Fish Oil Emulsion (Omegaven) as as source of nutrition in infants with parenteral nutrition associated cholestasis.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | Time in days from the initiation of fish oil emulsions (initiation of study) until resolution of cholestasis as defined by serum conjugated bilirubin≤ 2 mg/dL prior to EOS (end of study). |
| Primary | All Cause Mortality During the Study. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | To describe proportion of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion. |
| Primary | Growth Z-scores for Weight | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | The Z-score indicated the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean. A weight Z-score of ≤ -2 indicates an underweight status, while a weight Z-score of ≥ 2 indicates overweight or obese status. |
| Secondary | Number of Infants Who Achieve Resolution of Parenteral Nutrition Associated Cholestasis | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | To describe the number of infants who achieved resolution of cholestasis following initiation of fish oil emulsion. |
| Secondary | Number of Subjects With Platelet Count <100,000/µL | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | To describe the number of study subjects who experienced a platelet count below \<100,000/µL anytime during the duration of the study. |
| Secondary | Number of Subjects With INR ≥1.4. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | To describe the number of study subjects who experienced an INR ≥1.4 anytime during the duration of the study. |
| Secondary | Number of Study Subjects Who Experienced a Blood Stream Infection | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | To describe the number of study subjects who experienced a bloodstream infection during the duration of the study. Bloodstream infection as defined by detection by the culture of bacteria or fungus from the blood. |
| Secondary | Liver or Multi-visceral Transplant | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | To describe the number and percentage of infants who required liver or multi-visceral transplant. |
| Secondary | All-cause Mortality up to Hospital Discharge | Anytime from initiation of study to discharge from the hospital. | To describe number and percentage of infants who died secondary to any cause, related or unrelated to Fish Oil Emulsion. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | 210 out of 286 infants in the study demonstrated resolution of cholestasis prior to the end of study. | Days | MEAN |
| PRIMARY | All Cause Mortality During the Study. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Growth Z-scores for Weight | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | Out of 286 infants enrolled in the study, weight at the end of study was available only in 260 infants. Missing data: 26 infants. | z-score | MEAN |
| SECONDARY | Number of Infants Who Achieve Resolution of Parenteral Nutrition Associated Cholestasis | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | Only 285 out of 286 infants were included in this analysis. One infant had conjugated bilirubin \<2 mg/dL at the initiation of fish oil emulsion. This infant had been initiated on fish oil emulsion at another institute. Fish oil emulsion in this infant was provided as a continuation of care from another hospital. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Platelet Count <100,000/µL | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | Out of 286 infants enrolled in the study, weight at the end of study was available only in 264 infants. Missing data: 22 infants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With INR ≥1.4. | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | Out of 286 infants enrolled in the study, weight at the end of study was available only in 248 infants. Missing data: 38 infants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Study Subjects Who Experienced a Blood Stream Infection | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | Out of 286 infants enrolled in the study, weight at the end of study was available only in 283 infants. Missing data: 3 infants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Liver or Multi-visceral Transplant | From initiation to end of study (End of Study : Discontinuation of Fish Oil Emulsion, Death, Transplant, or Discharge from the hospital, whichever is achieved first, up to 5 years). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | All-cause Mortality up to Hospital Discharge | Anytime from initiation of study to discharge from the hospital. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study | Fish Oil Emulsion Arm | 38.02 | Standard Deviation 23.9 | Days | |
| All Cause Mortality During the Study. | Fish Oil Emulsion Arm | 30 | Participants | ||
| Growth Z-scores for Weight | Fish Oil Emulsion Arm | -1.48 | Standard Deviation 1.45 | z-score | |
| Number of Infants Who Achieve Resolution of Parenteral Nutrition Associated Cholestasis | Fish Oil Emulsion Arm | Resolution of Cholestasis | 210 | Participants | |
| Number of Infants Who Achieve Resolution of Parenteral Nutrition Associated Cholestasis | Fish Oil Emulsion Arm | Unresolved Cholestasis | 75 | Participants | |
| Number of Subjects With Platelet Count <100,000/µL | Fish Oil Emulsion Arm | Platelet count <100.000/uL | 124 | Participants | |
| Number of Subjects With Platelet Count <100,000/µL | Fish Oil Emulsion Arm | Platelet count >100,000uL | 140 | Participants | |
| Number of Subjects With INR ≥1.4. | Fish Oil Emulsion Arm | INR ≥ 1.4 | 75 | Participants | |
| Number of Subjects With INR ≥1.4. | Fish Oil Emulsion Arm | INR ≤ 1.4 | 173 | Participants | |
| Number of Study Subjects Who Experienced a Blood Stream Infection | Fish Oil Emulsion Arm | Blood stream infection | 88 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fish Oil Emulsion Arm | 293 | |
| Overall Study | COMPLETED | Fish Oil Emulsion Arm | 286 | |
| Overall Study | NOT COMPLETED | Fish Oil Emulsion Arm | 7 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | GGT>200 U/L | Hepatobiliary disorders | Fish Oil Emulsion Arm | 146 | 286 | |
| other | INR ≥ 1.4 | Blood and lymphatic system disorders | Fish Oil Emulsion Arm | 75 | 286 | |
| serious | Blood Stream Infection | Infections and infestations | Fish Oil Emulsion Arm | 88 | 286 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fish Oil Emulsion Arm | 30 | 286 |
| Total, other adverse events | Fish Oil Emulsion Arm | 148 | 286 |
| Total, serious adverse events | Fish Oil Emulsion Arm | 88 | 286 |
Source ClinicalTrials.gov
Papers27
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00738101
GET https://conductscience.org/api/trials/v1/NCT00738101/papers?page=2