Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD (NCT02357576) | Clinical Trial Compass
CompletedPhase 3
Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD
United States22 participantsStarted 2016-05-21
Plain-language 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
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 encep…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Rise of Direct Bilirubin as a Function of Time