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

March 27, 2025 updated by: Putri Maharani Tristanita Marsubrin, MD, PhD, Indonesia University

Pemberian Lipid Intravena Dosis Tinggi Untuk Bayi Sangat Prematur Atau Berat Lahir Sangat Rendah Terhadap Pertumbuhan

This is a RCT study conducted in Cipto Mangunkusumo Hospital in very preterm infants. The investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach birth weight.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Neonates with <32 weeks gestation age or <1500 gram birth weight gets early intravena lipid start with 2 gram per body weight and 1 gram per body weigh then observed the time to reach birth weight

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Jakarta
      • Jakarta, Central Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • birth weight below 1500 gram or gestational age below 32 weeks

Exclusion Criteria:

  • mayor congenital abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 gram
This group will get 2 g of lipid IV in the early 24 hours of life
Dietary supplement: Lipid IV 2 g
This group will get 2 g of lipid IV in the early 24 hours of life
Active Comparator: 1 gram
This group will get 1 g of lipid IV in the early 24 hours of life
Dietary supplement: lipid IV 1 gram
This group will get 1 g of lipid IV in the early 24 hours of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
return to birth weight
Time Frame: day
time of the participants to reach back the birth weight up to 28 days of age
day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Putri MT Marsubrin, MD, PhD, Cipto Mangunkusumo Hospital, Jakarta, Central Jakarta 10430

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

January 16, 2025

Study Completion (Estimated)

March 26, 2025

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPIP2GVS1G

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Very Preterm Birth

Clinical Trials on Lipid IV 2 g

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe