Preterm InfantsPhase 2NCT00497289

Comparison of Two Different Lipid Emulsions for Parenteral Nutrition in Preterm Infants

A Phase 2 study testing Lipofundin MCT/LCT 20 % and Lipidem 20% in people with Preterm Infants and Parenteral Nutrition n-3 Fatty Acids, run by B. Braun Melsungen AG at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study shall provide evidence for the save and efficient use of a fish oil containing lipid emulsion in parenteral nutrition of preterm infants.Safety will be assessed by monitoring hepatological and hematological laboratory parameters. Efficiency will be assessed by monitoring of inflammatory parameters. Read more about this study

Who is it for?: Ages 5 hours to 3 days
Conditions the study is for: Preterm Infants, Parenteral Nutrition n-3 Fatty Acids
What is being tested?: Lipofundin MCT/LCT 20 % and Lipidem 20%
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 2 sitesGermany
Study dates: Jan 2006to Feb 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 hours to 3 days
All sexes
No healthy volunteers
Child

Who may be able to join

prematurity (birth weight 500 - 1500 g)
postnatal age <= 72 h
need for cumulative parenteral energy supply of at least 70% during study duration
signed informed consent form

Who cannot join

simultaneous participation in another clinical study
platelet count below 50000 /ml
cumulative enteral energy supply of > 30 % during study duration
serious congenital infections and/or diseases
serious metabolic disturbances
severe cranial bleeding (Papile III, IV)

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need for administration of blood products
contra-indication for iv lipid administration
withdrawal of consent

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Ernst Moritz Arndt University , Childrens Hospital
Greifswald, 17487
Neonatology of the Pediatric University Hospital
Munich, Bavaria, 80337

Other trials in Germany

About this study

Official title: Double-blind, Prospective, Randomized Comparison of a Medium Chain Triglycerides (MCT)/Long Chain Triglycerides (LCT)/Fish Oil (FO) Containing 20% Lipid Emulsion With a MCT/LCT Emulsion (20%) for Parenteral Nutrition in Preterm Infants

Conditions: Preterm Infants, Parenteral Nutrition n-3 Fatty Acids
Being tested: Lipofundin MCT/LCT 20 %, Lipidem 20%
Keywords: n-3 Polyunsaturated Fatty Acids (PUFA), parenteral nutrition, preterm infant
Medical subject headings: Hyperphagia, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lipofundin MCT/LCT 20 %Drug
daily i.v. infusion for up to 5 days
Lipidem 20%Drug
daily i.v. infusion for up to 5 days

Study groups in NCT00497289
Study group	Role	What they receive
1	Experimental	Lipidem 20 % Receives: Drug: Lipidem 20%
2	Active comparator	Lipofundin MCT/LCT 20% Receives: Drug: Lipofundin MCT/LCT 20 %

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: Alanine Transaminase (ALT)
Change in ALT between pre/post treatment
Measured: on Study day -1 & 6
Efficacy: Interleukin-6 (IL-6)
Change of IL-6 Measurement pre/post treatment
Measured: on Study day -1 & 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Feb 2008

First posted6 Jul 2007 (estimated)
Study startJan 2006
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Preterm InfantsStudies of the same condition, open and under way.
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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00497289
Sponsor's protocol ID: HC-G-H-0404
Status last verified: Feb 2021
First submitted: 4 Jul 2007
Last updated: 10 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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RecruitingObservational study
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All Preterm Infants trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Prospective, Randomized Comparison of a Medium Chain Triglycerides (MCT)/Long Chain Triglycerides (LCT)/Fish Oil (FO) Containing 20% Lipid Emulsion With a MCT/LCT Emulsion (20%) for Parenteral Nutrition in Preterm Infants
ClinicalTrials.gov ID: NCT00497289
Acronym / sponsor ID: HC-G-H-0404
Conditions: Preterm Infants, Parenteral Nutrition n-3 Fatty Acids
Keywords: n-3 Polyunsaturated Fatty Acids (PUFA), parenteral nutrition, preterm infant
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: B. Braun Melsungen AGIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 6 Jul 2007 (estimated)
Results: Posted 10 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Lipidem 20%Lipidem 20 %
2	Active comparator	Drug: Lipofundin MCT/LCT 20 %Lipofundin MCT/LCT 20%

Who may qualify

Ages: 5 hours to 3 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

prematurity (birth weight 500 - 1500 g)
postnatal age <= 72 h
need for cumulative parenteral energy supply of at least 70% during study duration
signed informed consent form

Key exclusion criteria (9 listed)

simultaneous participation in another clinical study
platelet count below 50000 /ml
cumulative enteral energy supply of > 30 % during study duration
serious congenital infections and/or diseases
serious metabolic disturbances

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
Lipofundin MCT/LCT 20 %daily i.v. infusion for up to 5 days	Drug	2
Lipidem 20%daily i.v. infusion for up to 5 days	Drug	1

Primary outcome

Safety: Alanine Transaminase (ALT)
Time frame: on Study day -1 & 6
Change in ALT between pre/post treatment
Efficacy: Interleukin-6 (IL-6)
Time frame: on Study day -1 & 6
Change of IL-6 Measurement pre/post treatment

Results and safety

Results posted to the registry on 10 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lipidem 20 %	24	19
Lipofundin MCT/LCT 20%	24	18

Primary outcome: Safety: Alanine Transaminase (ALT)

Time frame: on Study day -1 & 6. Mean (Standard Deviation). Unit: U/L

Measure	MCT:LCT:FO / 5:4:1 n = 15	MCT:LCT / 1:1 n = 19
Value	-0.83 (4.61)	-3.27 (7.81)

MCT:LCT:FO / 5:4:1 vs MCT:LCT / 1:1: p = 0.3654, Wilcoxon (Mann-Whitney)

Population analysed: A duration of treatment with study medication over less than 6 days was regarded as the only major deviation from the protocol. Therefore all available values were used for analysis.

Primary outcome: Efficacy: Interleukin-6 (IL-6)

Time frame: on Study day -1 & 6. Mean (Standard Deviation). Unit: pg/mL

Measure	MCT:LCT:FO / 5:4:1 n = 19	MCT:LCT / 1:1 n = 17
Value	-42.23 (197.10)	-68.74 (101.67)

MCT:LCT:FO / 5:4:1 vs MCT:LCT / 1:1: p = 0.0264, Wilcoxon (Mann-Whitney)

Population analysed: Per protocol population

Adverse events

Time frame: From enrolment into study at least 6 days or longer if medically indicated.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MCT/LCT/FO-containing 20% Fat Emulsion	22 of 24 (91.7%)	24 of 24 (100%)	Not reported
MCT/LCT Emulsion (20%)	19 of 24 (79.2%)	24 of 24 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Preterm Infants

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant

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. This study is not recruiting at the moment.

Berthold V. Koletzko, Prof., MD principal investigator

Dr. von Hauner Children´s Hospital, University of Munich

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lipofundin MCT/LCT 20 % and Lipidem 20% in people with Preterm Infants and Parenteral Nutrition n-3 Fatty Acids, run by B. Braun Melsungen AG at 2 sites in Germany.

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 4 inclusion and 9 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: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety: Alanine Transaminase (ALT) (time frame: on Study day -1 & 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00497289.

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 10 Mar 2021.