Cholestasis Prevention: Efficacy of IV Fish Oil
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00512629 |
Recruitment Status :
Completed
First Posted : August 8, 2007
Last Update Posted : December 3, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholestasis Parenteral Nutrition | Drug: Omegaven Drug: Intralipid | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Cholestasis Prevention: Efficacy of IV Fish Oil |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Omegaven
Omegaven is a fish based intravenous fat emulsion
|
Drug: Omegaven
Omegaven is a fish based intravenous fat emulsion |
Active Comparator: Intralipid |
Drug: Intralipid
Intralipid is a plant based intravenous fat emulsion |
- Presence vs. absence of PN-associated cholestasis (PNAC) [ Time Frame: 6 months ]The definition of "Presence vs. Absence of PNAC" will vary with the post conceptual age of the child. In infants > 40 weeks post conceptual age, we will define PN-associated cholestasis as four consecutive measurements (> 6 days apart) of serum direct bilirubin > 2.0mg/dL obtained over a 30 day period in the absence of other demonstrable etiologies of cholestasis. Due to hepatic immaturity, for infants < 40 weeks post conceptual age, PN associated cholestasis will be defined as four consecutive measurements (> 6 days apart) of serum direct bilirubin > 2.0mg/dL obtained over a 42 day period.
- Fatty acid profiles [ Time Frame: 6 months ](i.e., Mead acid levels, triene:tetraene ratios, total omega-3 and omega-6 fatty acid levels, arachidonic acid levels)
- Weight and height gain [ Time Frame: 6 months ]
- Liver function tests [ Time Frame: 6 months ](i.e. serum triglycerides, cholesterol, ALT, AST and total and direct bilirubin levels)
- Death from PNALD liver or liver/gastrointestinal tract transplant. [ Time Frame: 1 year ]
- Duration of parenteral nutrition [ Time Frame: 6 months ](i.e. enteral feeding tolerance, including days to reach full enteral feeding (approximately 100-125kcal/kg/d + 10%) after randomization and the number of episodes of feeding intolerance (defined as an interruption of enteral feedings for > 12 hrs) , number of infants requiring TPN providing > 10% of total daily fluid volume at 12 weeks after randomization, and duration of TPN providing > 10% of total daily fluid intake)
- Frequency of blood stream infections [ Time Frame: 6 months ]
- Inflammatory markers (C-reactive protein), cytokine levels [ Time Frame: 6 months ]
- Incidence and severity of ROP [ Time Frame: 6 months ]
- Neurodevelopment Assessments [ Time Frame: 6, 12, & 24 months (corrected for gestational age) ]Neurodevelopment will be assessed at 6, 12, and 24 months (corrected) using Bayley Scales of Infant Development III(mean total, cognitive, language, and motor scaled score; and frequency of each score <70). The MSD parent questionnaire will be mailed at 12 and 24 months (corrected); and the Parent Report of Children's Abilities - Revised (PARCA-R) parent questionnaire will be mailed at 24 months (coorected).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 3 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria (all of the following):
- Congenital or acquired gastrointestinal disease requiring surgical intervention [such as Midgut volvulus, Gastroschisis-(with known or suspected atresia(s), perforation(s) requiring a jejunostomy, or bowel resections > 20cm), Omphalocele, Jejunal atresia or NEC-(no peritoneal drains) or duodenal atresia] ; and
- Expected dependence on parenteral nutrition for full or partial nutritional support for an anticipated duration of therapy of at least 21 days; Subjects will be judged by their clinical team to require PN support a minimum of 21 days based on the following criteria: inability to tolerate enteral feedings, lack of audible bowel sounds, contraindications to initiation of enteral feedings (e.g., grossly bloody stools or other sign of intestinal ischemia, hypotension, bilious emesis, or clinical or radiographic evidence of bowel obstruction); and
- Neonates and infants < 3 months of age (postnatally); and
- Gestational age > 28 weeks; and
- Baseline direct bilirubin less than 1.0 mg/dL (normal); and
- Weight > 1 kg
Exclusion criteria(any one of the following):
- Exposure to soybean oil fat emulsion for greater than three weeks (>21 days) at time of enrollment
- Known or suspected intolerance or allergy to any of the components of the study IFE, including fish, soy or egg protein
- Inability to obtain written informed consent prior to the baseline labs
- The patient is enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- Intention to transfer care to another patient facility within 3 months of baseline labs
- Any serum triglyceride level greater than 400 mg/dL at baseline
- History of severe hemolytic disorders or INR greater than 1.5 at baseline (INR cutoff of greater than 2 for babies less than 1 week of age)
- History of shock requiring vasopressors (dopamine equal or less than 20 micrograms/kilogram/minute is allowed; all other use of vasopressors is excluded)
- Preexisting liver disease, regardless of etiology
- Hemodynamically unstable as judged by PI
- Renal failure (creatinine greater than 0.4 mg/dL unless less than 1 month of age-then at the PI's discretion)
- Patient previously had STEP (Serial Transverse Enteroplasty Procedure)
- Patient is currently on ECMO or nitric oxide
- GGTP > 80 mg/L at baseline
- Weight < 1 kg at time of enrollment
- Gestational age < 28 weeks at time of enrollment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512629
United States, Massachusetts | |
Childrens's Hospital Boston | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Mark Puder, MD, PhD | Boston Children's Hospital |
Responsible Party: | Mark Puder, Medical Staff, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00512629 |
Other Study ID Numbers: |
06-03-0105 1R01FD003436-01 ( U.S. FDA Grant/Contract ) |
First Posted: | August 8, 2007 Key Record Dates |
Last Update Posted: | December 3, 2020 |
Last Verified: | December 2020 |
PN cholestasis gastrointestinal disease in infants short bowel syndrome |
Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
Soybean oil, phospholipid emulsion Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |