N/A N=293 Treatment

Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants

Cholestasis · Cholestasis of Parenteral Nutrition

Bottom Line

View on ClinicalTrials.gov: NCT00738101 ↗

Enrolled (actual)

293

Serious AEs

30.8%

Results posted

May 2020

Primary outcome: Primary: Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study — 38.02 Days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Omegaven (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Resolution of Parenteral Nutrition Associated Cholestasis Prior to End of Study	38.02	—
PRIMARY All Cause Mortality During the Study.	30	—
PRIMARY Growth Z-scores for Weight	-1.48	—
SECONDARY Number of Infants Who Achieve Resolution of Parenteral Nutrition Associated Cholestasis	210; 75	—
SECONDARY Number of Subjects With Platelet Count <100,000/µL	124; 140	—
SECONDARY Number of Subjects With INR ≥1.4.	75; 173	—
SECONDARY Number of Study Subjects Who Experienced a Blood Stream Infection	88; 195	—
SECONDARY Liver or Multi-visceral Transplant	2	—
SECONDARY All-cause Mortality up to Hospital Discharge	40	—

Summary

To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Eligibility Criteria

Inclusion Criteria

Be greater than 14 days old and less than 5 years old
Conjugated bilirubin greater than 2 mg/dL.
Be expected to require intravenous nutrition for at least an additional 28 days

Exclusion Criteria

Have a congenitally lethal condition (e.g. Trisomy 13).
Have clinically severe bleeding not able to be managed with routine measures.
Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

Home Use of Omegaven®:

In order for a subject to receive the Omegaven® at home through a home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®.

If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic.

Outpatient Monitoring:

After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00738101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.