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

NCT ID: NCT06909929

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-03-26

Brief Summary

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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.

Detailed Description

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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

Conditions

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Very Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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2 gram

This group will get 2 g of lipid IV in the early 24 hours of life

Group Type EXPERIMENTAL

Lipid IV 2 g

Intervention Type DIETARY_SUPPLEMENT

This group will get 2 g of lipid IV in the early 24 hours of life

1 gram

This group will get 1 g of lipid IV in the early 24 hours of life

Group Type ACTIVE_COMPARATOR

lipid IV 1 gram

Intervention Type DIETARY_SUPPLEMENT

This group will get 1 g of lipid IV in the early 24 hours of life

Interventions

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Lipid IV 2 g

This group will get 2 g of lipid IV in the early 24 hours of life

Intervention Type DIETARY_SUPPLEMENT

lipid IV 1 gram

This group will get 1 g of lipid IV in the early 24 hours of life

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* mayor congenital abnormalities
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Putri Maharani Tristanita Marsubrin, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Putri MT Marsubrin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cipto Mangunkusumo Hospital, Jakarta, Central Jakarta 10430

Locations

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Cipto Mangunkusumo Hospital

Jakarta, Central Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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LIPIP2GVS1G

Identifier Type: -

Identifier Source: org_study_id

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