Trial · NCT02370251
Compassionate Use of Omegaven in Children
NCT02370251, Phase 2, Phase 3, Completed, University of Oklahoma; results first posted 2019-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Compassionate Use of Omegaven in Children. Trials, record NCT02370251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02370251
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compassionate Use of Omegaven in Children
- NCT number
- NCT02370251
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 63 participants, actual
- Lead sponsor
- University of Oklahoma
- Conditions
- Total Parenteral Nutrition-induced Cholestasis, Cholestasis, Short Bowel Syndrome, Gastroschisis, Intestinal Atresia, Infant, Premature, Diseases, Cholestasis of Parenteral Nutrition
- Interventions
- Omegaven
- First posted
- 2015-02-24
- Last updated
- 2019-11-25
- Results first posted
- 2019-11-25
- Limitations and caveats
This was a compassionate use study, using Omegaven as a last resort for infants with a direct bilirubin of at least 2 mg/dL at the time of initiation, so these infants were already at higher risk of death and hematological/hepatobiliary morbidity.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Resolution of Cholestasis for Subjects Who Received Omegaven | Within the first 3 months of sole Omegaven use | To determine if Omegaven results in the resolution of cholestasis (DB \<2 for 2 consecutive weeks) |
| Secondary | Safety Issues for Infants Who Received Omegaven | Within the first year of use | To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated liver function tests, increased liver and/or intestinal transplant rates, or death |
| Secondary | Essential Fatty Acid Deficiency in Infants Who Received Omegaven | Within the first month of use | To determine if Omegaven can resolve essential fatty acid deficiency |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Resolution of Cholestasis for Subjects Who Received Omegaven | Within the first 3 months of sole Omegaven use | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety Issues for Infants Who Received Omegaven | Within the first year of use | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Essential Fatty Acid Deficiency in Infants Who Received Omegaven | Within the first month of use | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Resolution of Cholestasis for Subjects Who Received Omegaven | Omegaven | Cholestasis resolved within 3 months | 40 | Participants | |
| Resolution of Cholestasis for Subjects Who Received Omegaven | Omegaven | Cholestasis resolved after 3 months | 10 | Participants | |
| Resolution of Cholestasis for Subjects Who Received Omegaven | Omegaven | Cholestasis not resolved | 2 | Participants | |
| Safety Issues for Infants Who Received Omegaven | Omegaven | Baseline : INR >1.4 | 10 | Participants | |
| Safety Issues for Infants Who Received Omegaven | Omegaven | End of Treatment : INR >1.4 | 7 | Participants | |
| Safety Issues for Infants Who Received Omegaven | Omegaven | Baseline : Gamma-Glutamyl Transferase (GGT) >300 | 6 | Participants | |
| Safety Issues for Infants Who Received Omegaven | Omegaven | End of Treatment : GGT >300 | 7 | Participants | |
| Safety Issues for Infants Who Received Omegaven | Omegaven | Baseline : High-density Lipoprotein (HDL) <20 | 39 | Participants | |
| Safety Issues for Infants Who Received Omegaven | Omegaven | End of Treatment : HDL <20 | 24 | Participants | |
| Essential Fatty Acid Deficiency in Infants Who Received Omegaven | Omegaven | Did not have EFAD | 14 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omegaven | 63 | |
| Overall Study | COMPLETED | Omegaven | 52 | |
| Overall Study | NOT COMPLETED | Omegaven | 11 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Elevated INR | Blood and lymphatic system disorders | Omegaven | 4 | 52 | |
| serious | Elevated GGT | Hepatobiliary disorders | Omegaven | 5 | 52 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omegaven | 4 | 52 |
| Total, other adverse events | Omegaven | 0 | 52 |
| Total, serious adverse events | Omegaven | 9 | 52 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02370251
GET https://conductscience.org/api/trials/v1/NCT02370251/registered