Intralipid Regimens for Neurodevelopment in Preterm Infants

Recruiting in Palo Alto (17 mi)

Overseen by Lindsay N Fleig, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of usual versus reduced lipid intake on unbound bilirubin levels, brainstem auditory evoked responses, and neurodevelopmental outcome at 2 years in extremely preterm infants.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Intralipid Regimens for Neurodevelopment in Preterm Infants is an effective treatment?

The available research shows that Intralipid, a soybean oil-based intravenous lipid emulsion, is commonly used in parenteral nutrition for preterm infants. However, studies comparing Intralipid to other lipid emulsions like SMOFlipid, which includes fish oil, suggest that SMOFlipid may have some advantages. For instance, one study found that using SMOFlipid resulted in fewer cases of certain health issues like bronchopulmonary dysplasia and cholestasis compared to Intralipid. This suggests that while Intralipid is effective, there might be alternative treatments that offer better outcomes for specific conditions.

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What safety data exists for Intralipid regimens in preterm infants?

The safety data for Intralipid regimens in preterm infants includes several studies and observations. Intralipid, a soybean oil-based intravenous lipid emulsion, has been commonly used in parenteral nutrition. Studies have compared its effects with other lipid emulsions like SMOFlipid, which contains fish oil and has a different fatty acid profile. Research indicates that while Intralipid is effective for growth, SMOFlipid may reduce the prevalence of certain conditions like bronchopulmonary dysplasia and cholestasis, though it may increase the risk of late sepsis. Additionally, the formulation of Intralipid has evolved to meet pharmacopeial specifications for droplet size, ensuring its safety and efficacy. However, there is still a need for further research to optimize lipid emulsions for neurodevelopment and manage complications like hypertriglyceridemia in preterm infants.

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Is the Intralipid regimen a promising treatment for neurodevelopment in preterm infants?

Intralipid, a soybean oil-based intravenous lipid emulsion, is commonly used in preterm infants to support growth and provide essential nutrients. It helps deliver nonprotein calories and fatty acids, which are important for growth and development. While Intralipid is effective in promoting growth, newer formulations like SMOFlipid, which include a mix of oils, may offer additional benefits such as improved liver health and reduced risk of certain complications. However, Intralipid remains a valuable option for supporting the growth and development of preterm infants.

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Eligibility Criteria

This trial is for extremely preterm infants without major birth defects or infections, whose mothers consented to the Neonatal Research Network Cycled Phototherapy Trial. Infants who have already received intralipid treatments are not eligible.

Inclusion Criteria

I do not have any major birth defects or active infections.

Mother has consented to inclusion of the infant for the Neonatal Research Network (NRN) Cycled Phototherapy Trial

Exclusion Criteria

I have received Intralipid treatment.

Participant Groups

The study compares two lipid intake regimens in premature babies: a restricted and a usual prescribed intralipid regimen. It aims to see how these affect bilirubin levels, auditory brain responses, and neurodevelopment by age 2.

Group I: restricted prescribed intralipid (RL) regimen Experimental Treatment 1 Intervention

Group II: usual prescribed intralipid (UL) regimen Active Control 1 Intervention

restricted prescribed intralipid (RL) regimen is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Intralipid for:

• Parenteral nutrition for adults and pediatric patients

🇪🇺 Approved in European Union as Intralipid for:

• Parenteral nutrition for adults and pediatric patients

🇨🇦 Approved in Canada as Intralipid for:

• Parenteral nutrition for adults and pediatric patients

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Texas Health Science Center at Houston Houston, TX

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston Lead Sponsor

National Center for Advancing Translational Sciences (NCATS) Collaborator

References

1. China pubmed.ncbi.nlm.nih.gov

Clinical effects of multi-oil versus pure soybean oil-based lipid emulsions for preterm infants: An observational study. [2023] Conventional soybean oil-based intravenous lipid emulsions (SO-ILEs) have high polyunsaturated fatty acid (PUFA) contents and phytosterols that may have adverse effects in preterm infants. Recently, the multi-oil-based intravenous lipid emulsion (MO-ILE), SMOFlipid, has been widely utilized in the neonatal intensive care unit (NICU), but significant benefits over SO-ILEs in low gestational age neonates have yet to be demonstrated. This study was performed to compare the effects of the SO-ILE, Intralipid, and the MO-ILE, SMOFlipid, on neonatal health outcomes in preterm infants.

2. United States pubmed.ncbi.nlm.nih.gov

Dilemmas in the delivery of intravenous lipid emulsions and approach to hypertriglyceridemia in very preterm and low birth weight infants. [2023] Intravenous lipid emulsions (ILEs) are an essential component of parenteral nutrition for very preterm and very low birth weight infants (VLBWs). This article offers a perspective on advancements and controversies on ILE use in this population. ILEs prescribed after birth at a dose of 1.5-2 g/kg/day and advanced to 3 g/kg/day enhance growth. Growth appears to be similar for infants who receive an ILE composed of 100% soybean oil or a multi-oil ILE with 15% fish oil. 100% fish oil is the preferred ILE for the management of parenteral nutrition associated cholestasis and intestinal failure associated liver disease. Research is warranted to help determine how we can optimize ILEs to improve neurodevelopment and prematurity complications. Last, we lack a universal definition of hypertriglyceridemia (HTG) and consensus on triglyceride surveillance and HTG management. Investigation is required to determine the health impact of specific triglyceride ranges in very preterm infants and VLBWs.

3. Netherlands pubmed.ncbi.nlm.nih.gov

The pharmacopeial evolution of intralipid injectable emulsion in plastic containers: from a coarse to a fine dispersion. [2010] On December 1, 2007, the United States Pharmacopeia (USP) adopted Chapter 729 entitled Globule Size Distribution in Lipid Injectable Emulsions that contains two globule sizing methods and criteria to measure the mean droplet diameter (MDD) and the large-diameter tail of the globule size distribution to meet pharmacopeial specifications. The first of these measures, as the intensity-weighted MDD expressed in nanometers, must be less than 500 nm. The second measure, as the volume-weighted percentage of fat greater than 5 microm or PFAT(5), must be less than 0.05%. These limits were first suggested in 2001 based on an analysis of 16 lipid injectable emulsions available worldwide. In 2004, the packaging of the innovator lipid emulsion product Intralipid was changed from conventional glass bottles to plastic containers in the U.S. A subsequent analysis of the emulsion in its new container showed it to be more coarse than its previous glass counterpart and now failed the PFAT(5) limit. In 2007, it was announced that Intralipid in plastic containers was reformulated to meet the pharmacopeial limits. To track the time course of its transition from a coarse to a fine dispersion, 31 lots of Intralipid with expiration dates spanning five years were investigated.

4. England pubmed.ncbi.nlm.nih.gov

Dispelling myths about intravenous fish oil-based lipid emulsions: a clinical perspective. [2019] Intravenous lipid emulsions (IVLEs) are an essential component of parenteral nutrition. With the recent incorporation of new lipid emulsions into the Canadian and American market, the clinician responsible for prescribing these lipids should be educated regarding the different fatty acid (FA) profiles of these lipids, as well as their metabolic and functional effects.

5. United States pubmed.ncbi.nlm.nih.gov

Morbidity Outcomes of Very Low Birth Weight Neonates Receiving Parenteral Nutrition with Fish Oil Enriched Lipid Emulsion or Lipid Emulsion with Soybean Oil: An Observational Study. [2021] Intralipid (Fresenius Kabi) was the most commonly used lipid emulsion in parenteral nutrition (PN), with a 100% soybean oil composition, a low vitamin E content, and a &#969;-6: &#969;-3 ratio of 7:1. A recent alternative formulation is SMOFlipid (Fresenius Kabi), with a &#969;-6: &#969;-3 ratio of 5:2 and higher vitamin E content. A retrospective observational study was conducted to determine neonatal morbidity in very low birth weight (VLBW) premature infants during two periods: P1, when PN was based exclusively on Intralipid, and P2, when only SMOFlipid was supplied. In total, 170 VLBW neonates were analyzed, of whom 103 received PN for more than 6 days, 56 during P1, and 47 during P2. In both periods, the antenatal and neonatal characteristics of the cohort were comparable. In this analysis, the prevalence of associated comorbidities was determined. During P2, there were fewer cases of moderate to severe bronchopulmonary dysplasia (BPD) and of cholestasis, but more cases of late sepsis, mainly Staphylococcus epidermidis. No changes in the prevalence of other neonatal comorbidities were observed. We believe that the SMOFlipid used in PN could discreetly improve the prevalence of cholestasis or BPD.

6. United States pubmed.ncbi.nlm.nih.gov

Parenteral Nutrition in the Neonatal Intensive Care Unit: Intravenous Lipid Emulsions. [2023] Intravenous lipid emulsions (ILEs) are a source of nonprotein calories and fatty acids and help promote growth in preterm infants and infants with intestinal failure. An ILE dose and oil source determines its fatty acid, phytosterol, and vitamin E delivery. These factors play a role in the infant's risk for essential fatty acid deficiency and cholestasis, and help modulate inflammation, immunity, and organ development. This article reviews different ILEs and their constituents and their relationship with neonatal health.

7. United States pubmed.ncbi.nlm.nih.gov

An Observational Study of Smoflipid vs Intralipid on the Evolution of Intestinal Failure-Associated Liver Disease in Infants With Intestinal Failure. [2021] SMOFlipid has a more diverse lipid profile than traditional Intralipid and has become the standard lipid for patients in our intestinal rehabilitation program. Our objective was to compare outcomes in neonates with intestinal failure (IF) who received SMOFlipid against those receiving Intralipid.