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Search / Trial NCT06909929

High-Dose Intravenous Lipid for Very Preterm or Very Low Birth Weight Infants Effects on Growth

Launched by INDONESIA UNIVERSITY · Mar 27, 2025

Trial Information

Current as of November 07, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This randomized trial is testing whether giving a higher dose of intravenous lipids (2 g per kg of body weight) in the first 24 hours after birth helps very preterm or very low birth weight babies reach their birth weight faster. It’s being done at Cipto Mangunkusumo Hospital in Jakarta, Indonesia. Babies born before 32 weeks or weighing less than 1500 grams are randomly assigned to receive either 2 g/kg or 1 g/kg of lipid IV within the first day of life, and doctors will track how long it takes each infant to return to their birth weight, up to 28 days.

Eligible participants are all sexes, with birth weight under 1500 g or gestational age under 32 weeks, and no major birth defects. The study plans to enroll about 70 babies and is currently enrolling by invitation. It uses a single-masked design, where the investigators evaluating outcomes don’t know which lipid dose was given. Results are not yet available. The trial is led by Indonesia University, at Cipto Mangunkusumo Hospital.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • birth weight below 1500 gram or gestational age below 32 weeks
  • Exclusion Criteria:
  • mayor congenital abnormalities

About Indonesia University

Indonesia University is a leading academic institution dedicated to advancing healthcare through rigorous clinical research. As a trial sponsor, the university leverages its extensive expertise in medical science and collaboration with top-tier researchers to design and implement innovative clinical trials. Committed to ethical standards and patient safety, Indonesia University aims to contribute to the global body of knowledge in medicine, enhance therapeutic options, and improve health outcomes for diverse populations. Through its comprehensive approach, the university fosters an environment of scientific inquiry and collaboration, driving progress in clinical research and education.

Locations

Jakarta, Central Jakarta, Indonesia

Patients applied

0 patients applied

Trial Officials

Putri MT Marsubrin, MD, PhD

Principal Investigator

Cipto Mangunkusumo Hospital, Jakarta, Central Jakarta 10430

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported