High-Dose Intravenous Lipid for Very Preterm or Very Low... | NCT06909929

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

NCT06909929

Sponsor

Indonesia University

Status

Enrolling by invitation

Last Update Posted

Apr 4, 2025Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Very Preterm Birth

Interventions

Lipid IV 2 g
lipid IV 1 gram

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Jan 16, 2025Actual

Completion Date

Mar 26, 2025Estimated

First Submitted Date

Dec 19, 2024

First Submission Date that Met QC Criteria

Mar 27, 2025

First Posted Date

Apr 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Apr 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Putri Maharani Tristanita Marsubrin, MD, PhD, Principal Investigator, Indonesia UniversityPrincipal Investigator

Lead Sponsor

Indonesia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lipid IV 2 g	Dietary Supplement	This group will get 2 g of lipid IV in the early 24 hours of life	2 gram

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

birth weight below 1500 gram or gestational age below 32 weeks

Exclusion Criteria:

mayor congenital abnormalities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Putri MT Marsubrin, MD, PhD	Cipto Mangunkusumo Hospital, Jakarta, Central Jakarta 10430	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo Hospital		Jakarta	Central Jakarta	10430	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C037242	Lipid IV

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided