NCT06909929

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

December 19, 2024

Last Update Submit

March 27, 2025

Conditions

Very Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • return to birth weight

    time of the participants to reach back the birth weight up to 28 days of age

    day

Study Arms (2)

2 gram

EXPERIMENTAL

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

Dietary Supplement: Lipid IV 2 g

1 gram

ACTIVE COMPARATOR

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

Dietary Supplement: lipid IV 1 gram

Interventions

Lipid IV 2 gDIETARY_SUPPLEMENT

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

2 gram
lipid IV 1 gramDIETARY_SUPPLEMENT

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

1 gram

Eligibility Criteria

AgeUp to 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • mayor congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, Central Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Lipid IV

Study Officials

  • Putri MT Marsubrin, MD, PhD

    Cipto Mangunkusumo Hospital, Jakarta, Central Jakarta 10430

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2024

First Posted

April 4, 2025

Study Start

September 1, 2024

Primary Completion

January 16, 2025

Study Completion

March 26, 2025

Last Updated

April 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)