Preterm InfantPhase 4NCT04277923
Effects of Fat Emulsions on PNALD and Oxidative Stress in Premature Infants
A Phase 4 study testing SMOFlipid and Lipofundin in people with Preterm Infant, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Abnormal liver function or cholestasis is the result of multiple factors, include low birth weight, smaller than gestational age, preterm birth, infection, lipid emulsion (LE) in parenteral nutrition (PN), insufficient enteral nutrition (EN) etc. Most are inevitable, but the LEs in PN can be selected. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Preterm Infant
- What is being tested?
- SMOFlipid and Lipofundin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants (gestational age < 32 weeks) with birth weight < 1500g were admitted to NICU of Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China within 24 hours after birth
- No contraindications to parenteral nutrition
- Expected PN support for 14 days or more
- Parents or guardians agree
Who cannot join
- Parenteral nutrition support was provided prior to enrollment
- EN calorie for 10% or more
- Congenital intestinal structural/functional abnormalities
- Liver function damage caused by viral hepatitis, genetic metabolism and abnormal biliary tract
- Congenital or acquired immunodeficiency
- Complex congenital heart disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Medium and Long Chain Fat Emulsions and SMOF Fat Emulsions on PNALD and Oxidative Stress in Premature Infants: a Randomized, Double-blind Controlled Study
Abnormal liver function or cholestasis is the result of multiple factors, include low birth weight, smaller than gestational age, preterm birth, infection, lipid emulsion (LE) in parenteral nutrition (PN), insufficient enteral nutrition (EN) etc. Most are inevitable, but the LEs in PN can be selected. So the investigators compare two LEs, and want to see if the SMOF LE can improve hepatic index in preterm infants.
Read the detailed description
For preterm infants, especially for very or extremely low birth weight infants, it's impossible to achieve total enteral feeding in short time. So, PN has played an important role to sustain normal life. But, it also has an adverse effect on liver namely parenteral nutrition-associated liver disease (PNALD). LE(s) in PN has been showed to result in PNALD. So changing the type of LEs has been an ideal solution.
Two types of lipid emulsions are currently used for pediatric patients: one LE(the second generation) is composed of 50% long-chain triacylglycerols (LCTs) and 50% medium-chain triacylglycerols (MCTs), prepared from soybean oil and coconut oil respectively. A new LE (SMOF) contains 30% LCTs, 30% MCTs, 25% olive oil, and 15% fish oil. SMOF is rich in omega-3 polyunsaturated fatty acids which derived from fish oil. It may reduce inflammation in premature infants, prevent or treat cholestasis, and reduce oxidative stress.
Because of the different compositions, they have different effect on liver, inflammation, oxidative stress, etc. Therefore, the investigators designed a prospective, randomized and double-blind study to compare the different LEs (MCTs/LCTs and SMOF), so as to select a more suitable fat emulsion for premature infants in order to improve clinical outcomes.
- Conditions
- Preterm Infant
- Being tested
- SMOFlipid, Lipofundin
- Keywords
- parenteral nutrition, lipid emulsion, SMOF, PNALD, oxidative stress
- Medical subject headings
- Premature Birth, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFlipidDrug
the lipid of all-in-one is less than 4g/kg.d
LipofundinDrug
the lipid of all-in-one is less than 4g/kg.d
| Study group | Role | What they receive |
|---|---|---|
| SMOF lipid emulsion | Experimental | the SMOF lipid emulsion is SMOFlipid. Receives: Drug: SMOFlipid |
| MCT/LCT lipid emulsion | Experimental | the MCT/LCT lipid emulsion is Lipofundin. Receives: Drug: Lipofundin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of liver function indexes
liver enzyme in u/L
Measured: change from baseline in liver function indexes at 7 days and 14 days
Change of bilirubin indexes
bilirubin in μmol/L
Measured: change from baseline in bilirubin indexes at 7 days and 14 days
Secondary outcomes (3)
Change of superoxidase dismutase
superoxidase dismutase in u/L
Measured: change from baseline in superoxidase dismutase at 7 days and 14 days
Change of malondialdehyde
malondialdehyde in nmol/ml
Measured: change from baseline in malondialdehyde at 7 days and 14 days
Change of inflammatory factors
IL-1B, IL-2R, IL-6, IL-8, IL-10 and TNF-α in pg/ml
Measured: change from baseline in fatty acid at 7 days and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Wang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Ying Wang, Phd, Principal investigator, Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277923
- Sponsor's protocol ID
- PNALD
- Status last verified
- Feb 2020
- First submitted
- 6 Jan 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Medium and Long Chain Fat Emulsions and SMOF Fat Emulsions on PNALD and Oxidative Stress in Premature Infants: a Randomized, Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT04277923
- Acronym / sponsor ID
- PNALD
- Conditions
- Preterm Infant
- Keywords
- parenteral nutrition, lipid emulsion, SMOF, PNALD, oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 20 Feb 2020 (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.
Abnormal liver function or cholestasis is the result of multiple factors, include low birth weight, smaller than gestational age, preterm birth, infection, lipid emulsion (LE) in parenteral nutrition (PN), insufficient enteral nutrition (EN) etc. Most are inevitable, but the LEs in PN can be selected. So the investigators compare two LEs, and want to see if the SMOF LE can improve hepatic index in preterm infants.
Detailed description
For preterm infants, especially for very or extremely low birth weight infants, it's impossible to achieve total enteral feeding in short time. So, PN has played an important role to sustain normal life. But, it also has an adverse effect on liver namely parenteral nutrition-associated liver disease (PNALD). LE(s) in PN has been showed to result in PNALD. So changing the type of LEs has been an ideal solution.
Two types of lipid emulsions are currently used for pediatric patients: one LE(the second generation) is composed of 50% long-chain triacylglycerols (LCTs) and 50% medium-chain triacylglycerols (MCTs), prepared from soybean oil and coconut oil respectively. A new LE (SMOF) contains 30% LCTs, 30% MCTs, 25% olive oil, and 15% fish oil. SMOF is rich in omega-3 polyunsaturated fatty acids which derived from fish oil. It may reduce inflammation in premature infants, prevent or treat cholestasis, and reduce oxidative stress.
Because of the different compositions, they have different effect on liver, inflammation, oxidative stress, etc. Therefore, the investigators designed a prospective, randomized and double-blind study to compare the different LEs (MCTs/LCTs and SMOF), so as to select a more suitable fat emulsion for premature infants in order to improve clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMOF lipid emulsion | Experimental | Drug: SMOFlipidthe SMOF lipid emulsion is SMOFlipid. |
| MCT/LCT lipid emulsion | Experimental | Drug: Lipofundinthe MCT/LCT lipid emulsion is Lipofundin. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature infants (gestational age < 32 weeks) with birth weight < 1500g were admitted to NICU of Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China within 24 hours after birth
- No contraindications to parenteral nutrition
- Expected PN support for 14 days or more
- Parents or guardians agree
Key exclusion criteria (6 listed)
- Parenteral nutrition support was provided prior to enrollment
- EN calorie for 10% or more
- Congenital intestinal structural/functional abnormalities
- Liver function damage caused by viral hepatitis, genetic metabolism and abnormal biliary tract
- Congenital or acquired immunodeficiency
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 |
|---|---|---|
| SMOFlipidthe lipid of all-in-one is less than 4g/kg.d | Drug | SMOF lipid emulsion |
| Lipofundinthe lipid of all-in-one is less than 4g/kg.d | Drug | MCT/LCT lipid emulsion |
Primary outcome
Change of liver function indexes
Time frame: change from baseline in liver function indexes at 7 days and 14 days
liver enzyme in u/L
Change of bilirubin indexes
Time frame: change from baseline in bilirubin indexes at 7 days and 14 days
bilirubin in μmol/L
3 secondary outcomes
Change of superoxidase dismutase
Time frame: change from baseline in superoxidase dismutase at 7 days and 14 days
Change of malondialdehyde
Time frame: change from baseline in malondialdehyde at 7 days and 14 days
Change of inflammatory factors
Time frame: change from baseline in fatty acid at 7 days and 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
Related trials for Preterm Infant
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.
Ying Wang, Phd principal investigator
Xin Hua Hospital, School of Medicine, Shanghai Jiao Tong University,China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SMOFlipid and Lipofundin in people with Preterm Infant, run by Shanghai Jiao Tong University School of Medicine.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Wang, Phd (8613611884226, wangying_ssmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of liver function indexes (time frame: change from baseline in liver function indexes at 7 days and 14 days). 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?
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 20 Feb 2020.