Study Comparing SMOF Lipid and Intralipid in Children and Teens Undergoing Stem Cell Transplant for Acute Leukemia Effects on Blood Markers, Recovery, and Complications

What this Trial Is About

Researchers are comparing two types of fat components used in total parenteral nutrition TPN for children and adolescents aged 2 to 18 years with acute leukemia who are candidates for hematopoietic stem cell transplantation HSCT. The study aims to see if SMOF lipid leads to better graft success, fewer complications after surgery, and less malnutrition compared to Intralipid. This randomized trial is sponsored by Shahid Beheshti University and includes both male and female participants. Participants will be randomly assigned to receive TPN with either SMOF lipid or Intralipid as the fat component. Before transplantation and at days 15 and 30 after, blood samples will be collected to measure biochemical markers like cholesterol, blood sugar, albumin, electrolytes, inflammatory markers, and blood counts. Nutritional intake and appetite will also be assessed. Clinical outcomes such as graft engraftment, infections, bleeding, acute graft-versus-host disease, cholestasis, hospitalization, and mortality will be monitored throughout the study. During the study, participants will be closely followed with blood tests and physical measurements including mid-arm circumference and weight. Researchers will track the time to neutrophil and platelet engraftment and observe nutrition status, including oral intake and duration of parenteral nutrition. Outcomes will be collected for up to 7 weeks after transplantation, with some measures followed for up to 100 days. This comprehensive monitoring will help assess the effects of SMOF lipid versus Intralipid on transplant success and recovery.

Comparison of Intralipid With SMOF Lipid Following HSCT