RecruitingNot ApplicableNCT06625372

Comparison of Intralipid With SMOF Lipid Following HSCT

Comparison of the Effect of Intralipid Parenteral Nutritional With SMOF Lipid Parenteral Nutritional on Biochemical Markers, Hematologic Markers, and Clinical Outcomes Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)


Sponsor

Shahid Beheshti University

Enrollment

50 participants

Start Date

Oct 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to have a successful engraftment in after bone transplantation. Acute leukemia patient of both sexes aged 2 to 18 years, who are transplant candidates, participate in this study. Primary hypothesis is Patients receiving SMOF LIPID will have better grafts than patients receiving intralipid. Also, complications after surgery and malnutrition will be less in this group.


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Inclusion Criteria7

  • Willingness to cooperate and complete the informed consent form by the legal guardian of the child;
  • Age ≤ 18 years;
  • Definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● cell transplantation;
  • Eligible for parenteral nutrition support;
  • No contraindications for parenteral nutrition;
  • No history of allergy to egg or soy protein;
  • Absence of severe organ failure or impaired liver function test (bilirubin \> 2.5 mg/dL).

Exclusion Criteria4

  • Death of the child earlier than 5 days from the start of the intervention;
  • Unwillingness to continue cooperation during study;
  • Occurrence of side effects during the study;
  • In case of sepsis, hypotension, shock, thrombosis, myocardial infarction, liver dysfunction, the patient will be excluded from the study.

Interventions

DIETARY_SUPPLEMENTSMOF lipid

The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.

DIETARY_SUPPLEMENTINTRALIPIDS

The Intralipid will be given to the patient as fat component of total parenteral nutrition.


Locations(1)

Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran

Tehran, Iran

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NCT06625372


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