Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

NCT ID: NCT02357576

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-21
• Study Completion Date: 2019-11-08

Brief Summary

Parenteral nutrition-associated cholestasis (PNAC) and liver disease (PNALD) are associated with significant morbidity and mortality in neonates and is felt to be exacerbated by soybean-based lipid emulsions. Much research is currently being directed at identifying ways to reduce this risk. Reduction of the dose of soybean-based lipid given as a component of parenteral nutrition is one possible strategy. In this study we will compare standard dosing of soybean-based lipid (up to 3/kg/day) with a minimized dose (1 g/kg/day) and evaluate for the development of cholestasis and adequate growth between the two groups. Longterm followup will include an assessment of neurodevelopmental outcomes at 12 and 24 months of age.

Funding source - FDA OOPD

Conditions

Cholestasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Reduced Lipid

Subjects will receive a minimized dose (1 g/kg/day) of the soybean-based lipid component of parenteral nutrition.

Group Type: EXPERIMENTAL

Intralipid 20% I.V. Fat Emulsion

Intervention Type: DRUG

Standard Lipid

Subjects will receive the standard dose (up to 3 g/kg/day) of the soybean-based lipid component of parenteral nutrition.

Group Type: ACTIVE_COMPARATOR

Intralipid 20% I.V. Fat Emulsion

Intervention Type: DRUG

Interventions

Intralipid 20% I.V. Fat Emulsion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• neonates and infants who are at least 28 weeks corrected gestational age at the time of enrollment who are parenteral nutrition (PN) naive
• current direct bilirubin <2 mg/dL
• any of the following conditions:
• meconium ileus and peritonitis
• gastroschisis
• omphalocele >4cm or with liver herniated outside of the abdominal cavity
• necrotizing enterocolitis requiring surgical intervention
• volvulus
• intestinal atresia with >50% bowel loss

Exclusion Criteria

• weight <1 kg
• metabolic pathway defect which is associated with liver dysfunction in the neonatal period, including: hereditary fructose intolerance, galactosemia due to transferase deficiency and neonatal tyrosinemia, and/or disorder of lipid metabolism
• hepatic insufficiency as documented by either a biopsy with cirrhosis and/or marked aberration in synthetic function
• renal failure
• primary or secondary liver disease, regardless of liver function (includes hepatitis)
• use of extracorporeal membrane oxygenation (ECMO)
• suspected congenital obstruction of the hepatobiliary tree
• documented active infection which may be communicable, including infections hepatitis or HIV
• previous receipt of choleretic agents
• currently receiving phenobarbital or other barbiturates
• history of PNAC
• direct bilirubin >=2 mg/dL at time of enrollment
• congenital or acquired anomaly which will require major cardiovascular surgery
• major congenital or chromosomal anomaly
• hypoxic ischemic encephalopathy
• congenital defect of the brain
• major seizure disorder

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: collaborator

Primary Children's Hospital

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Meghan A. Arnold, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meghan A Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Colorado/Children's Hospital Colorado

Aurora, Colorado, United States

University of Florida

Gainesville, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01FD005085-01A1

Identifier Type: FDA

Identifier Source: secondary_id

View Link

HUM00075458

Identifier Type: -

Identifier Source: org_study_id