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Search / Trial NCT06915441

Lipid Infusions to Optimize Nutrition Trial

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Apr 3, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Soybean Oil Based Lipid Emulsion (Sole) Mixed Oil Lipid Emulsion (Mole)

ClinConnect Summary

The Lipid Infusions to Optimize Nutrition Trial is a research study designed to find out which type of lipid (fat) supplement is better for very premature infants at risk for lung problems and developmental delays. Specifically, the study will compare two kinds of lipid emulsions: a mixed oil lipid emulsion (MOLE) and a soybean oil-based lipid emulsion (SOLE). Researchers want to see if one of these options helps babies survive without developing bronchopulmonary dysplasia (a serious lung condition), improves their growth before they leave the hospital, and supports their brain development as they grow.

To participate in this trial, infants must be born before 28 weeks of pregnancy or weigh less than 1000 grams (about 2.2 pounds) and must survive at least 12 hours after birth. However, infants who have major health issues or infections, or who might not survive long, are not eligible. The trial is not yet recruiting participants, but once it starts, families can expect to learn more about how these lipid supplements could potentially improve their baby’s health outcomes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • inborn \<28 weeks gestational age (GA) or ≤1000g birth weight (BW)
  • survives until 12 hours after birth.
  • Exclusion Criteria:
  • Infants who are unable to be enrolled by 96 hours postnatal age
  • Major anomaly
  • Overt non-bacterial infection
  • Infants likely to expire soon defined as limiting or withdrawal of intensive care recommended or requested by the parents.

About The University Of Texas Health Science Center, Houston

The University of Texas Health Science Center at Houston (UTHealth) is a leading academic institution dedicated to advancing health through education, research, and clinical practice. As a prominent sponsor of clinical trials, UTHealth leverages its extensive resources and expertise in biomedical research to facilitate innovative studies aimed at improving patient outcomes. The institution is committed to fostering a collaborative environment that promotes scientific discovery and the translation of research findings into effective healthcare solutions, all while adhering to the highest ethical standards and regulatory guidelines. With a multidisciplinary approach, UTHealth plays a critical role in addressing complex health challenges and enhancing the quality of life in diverse communities.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Lindsay Holzapfel, MD, MS

Principal Investigator

The University of Texas Health Science Center, Houston

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported