Very Preterm BirthNCT06909929
High-Dose Intravenous Lipid for Very Preterm or Very Low Birth Weight Infants Effects on Growth
A study testing Lipid IV 2 g and lipid IV 1 gram in people with Very Preterm Birth, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Very Preterm Birth
- What is being tested?
- Lipid IV 2 g and lipid IV 1 gram
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2024to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth weight below 1500 gram or gestational age below 32 weeks
Who cannot join
- mayor congenital abnormalities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- Very Preterm Birth
- Being tested
- Lipid IV 2 g, lipid IV 1 gram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid IV 2 gDietary supplement
This group will get 2 g of lipid IV in the early 24 hours of life
lipid IV 1 gramDietary supplement
This group will get 1 g of lipid IV in the early 24 hours of life
| Study group | Role | What they receive |
|---|---|---|
| 2 gram | Experimental | This group will get 2 g of lipid IV in the early 24 hours of life Receives: 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 Receives: Dietary Supplement: lipid IV 1 gram |
What is being measured
The primary outcome is the main question the study is designed to answer.
return to birth weight
time of the participants to reach back the birth weight up to 28 days of age
Measured: day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Sep 2024
- Primary completion16 Jan 2025
- Study completion26 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Preterm BirthStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putri Maharani Tristanita Marsubrin, MD, PhD, Universitas Indonesia
- Investigators
- Putri MT Marsubrin, MD, PhD, Principal investigator, Cipto Mangunkusumo Hospital, Jakarta, Central Jakarta 10430
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909929
- Sponsor's protocol ID
- LIPIP2GVS1G
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pemberian Lipid Intravena Dosis Tinggi Untuk Bayi Sangat Prematur Atau Berat Lahir Sangat Rendah Terhadap Pertumbuhan
- ClinicalTrials.gov ID
- NCT06909929
- Acronym / sponsor ID
- LIPIP2GVS1G
- Conditions
- Very Preterm Birth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 26 Mar 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 gram | Experimental | Dietary Supplement: Lipid IV 2 gThis group will get 2 g of lipid IV in the early 24 hours of life |
| 1 gram | Active comparator | Dietary Supplement: lipid IV 1 gramThis group will get 1 g of lipid IV in the early 24 hours of life |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- birth weight below 1500 gram or gestational age below 32 weeks
Key exclusion criteria (1 listed)
- mayor congenital abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid IV 2 gThis group will get 2 g of lipid IV in the early 24 hours of life | Dietary supplement | 2 gram |
| lipid IV 1 gramThis group will get 1 g of lipid IV in the early 24 hours of life | Dietary supplement | 1 gram |
Primary outcome
return to birth weight
Time frame: day
time of the participants to reach back the birth weight up to 28 days of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Very Preterm Birth
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Recruiting
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
Prematurity
Active, not recruiting
Serial Brain MRI in Hospitalized Preterm Infants
Preterm Birth Complication
Not yet recruiting
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
Premature Birth, Infant, Premature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Putri MT Marsubrin, MD, PhD principal investigator
Cipto Mangunkusumo Hospital, Jakarta, Central Jakarta 10430
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipid IV 2 g and lipid IV 1 gram in people with Very Preterm Birth, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
return to birth weight (time frame: day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.