Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512629
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2007-08-06
Brief Title:
Cholestasis Prevention Efficacy of IV Fish Oil
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Cholestasis Prevention Efficacy of IV Fish Oil
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parenteral nutrition PN solutions are life saving in patients with surgical gastrointestinal diseases However the use of PN in pediatric populations especially premature infants is frequently associated with liver injury that may ultimately result in hepatic failure In studies conducted in a murine model we observed that intravenous fat emulsions IFE comprised of omega-3 fatty acids were able to prevent the development of cholestasis a common precursor of PN-associated liver disease as well as reverse preexisting PNALD through a combination of factors including improved triglyceride clearance coupled with anti-inflammatory properties In a case series treating patients with hepatic cholestasis serum bilirubin levels decreased markedly after the parenteral administration of an omega-3 fatty acid based fat emulsion Omegaven Patients tolerated this therapy and no adverse reactions attributed to its use were observed Based on results of these previous studies we propose to conduct a randomized trial aiming to gain preliminary evidence of efficacy of an omega-3 fatty acid based IFE in preventing PNALD in children with intestinal failure
Detailed Description:
We propose to conduct a randomized controlled clinical trial to determine whether the use of an omega-3 fatty acid based IFE in infants with surgical gastrointestinal disease will improve clinical outcomes compared to infants treated with standard IFE up to 6 months post randomization Neonates and infants 3 months old postnatally with surgical gastrointestinal disease defined as congenital or acquired gastrointestinal disease requiring PN for more than 21 days will be eligible for enrollment Patients who meet all inclusion and exclusion criteria will be randomized to receive PN with either Intralipid or Omegaven The appearance of both IFEs is indistinguishable so patients families and the medical care team will be blinded to treatment group allocation Aside from the IFE type the clinical care of both groups of infants will remain unchanged including standard use of feeding advancement protocols and treatment of underlying gastrointestinal and other diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01FD003436-01 | FDA | None | httpsreporternihgovquickSearch1R01FD003436-01 |