Evidence map›Paper›PMID 40415417›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2025

Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric randomized controlled trial.

Cynthia Blanco, Weili Chang, Abhay J Bhatt, Erick Gerday, Ajay J Talati, Narendra Dereddy, Rachana Singh, Erika Ryan, Thibault Senterre

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04555044 (A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04555044 phase4completednot on this map

A Randomized, Double-Blind, Controlled, Clinical Trial to Evaluate the Risk of Developing Essential Fatty Acid Deficiency in Pediatric Patients, Including Neonates, Receiving Either Clinolipid (Lipid Injectable Emulsion, USP) 20% or Standard-of-Care Soybean Oil-Based Lipid Emulsion (Part A)

TypeinterventionalSponsorBaxter Healthcare CorporationRan2021 to 2022Enrolled101ConditionsEssential Fatty Acid Deficiency (EFAD)ArmsClinolipid, Intralipid
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. [Interpretation of the "Expert consensus on the management of neonatal parenteral nutrition (2025)"].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Cynthia BlancoDivision of Neonatology, University of Texas Health Science Center, San Antonio, Texas, USA.ORCID https://orcid.org/0000-0001-7496-8709
Weili ChangDivision of Neonatology, East Carolina University Health Medical Center, Greenville, North Carolina, USA.
Abhay J BhattDivision of Neonatology, University of Mississippi Medical Center, Jackson, Mississippi, USA.
Erick GerdayDivision of Neonatology, Utah Valley Hospital, Provo, Utah, USA.
Ajay J TalatiDepartment of Pediatrics, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.
Narendra DereddyDivision of Neonatology, AdventHealth for Children, Orlando, Florida, USA.
Rachana SinghDepartment of Pediatrics, Tufts University School of Medicine, Boston, Massachusetts, USA.
Erika RyanBaxter Healthcare Corporation, Deerfield, Illinois, USA.
Thibault SenterreBaxter Healthcare Corporation, Deerfield, Illinois, USA.ORCID https://orcid.org/0009-0003-6228-4846

Funding

Baxter
6 · The paper itself

Abstract

objectivesThere is a concern that decreasing soybean oil (SO) content in intravenous lipid emulsions (ILEs) may increase the risk for essential fatty acid deficiency (EFAD). This study evaluates the risk of EFAD in pediatric patients who were expected to require parenteral nutrition for at least 7 days with an 80% olive oil/20% SO ILE (OO/SO group) versus a 100% SO ILE (SO group).

methodsThis randomized, double-blind, controlled, multicenter study evaluated 101 pediatric patients including 94 preterm infants. The primary outcome was the incidence of EFAD, including the analysis of the plasma fatty acid (FA) profiles and genetic polymorphism in the FA desaturase genes in patients with extreme arachidonic acid values.

resultsTreatment duration was 10.3 ± 7.8 and 11.3 ± 9.4 days in the OO/SO and SO groups respectively. No EFAD was observed. Linoleic acid values increased in both groups but to a lesser extent in the OO/SO group. Arachidonic acid values remained stable within the two groups. The changes in mead acid value were opposite in the two groups, demonstrating an increase in the OO/SO group and a decrease in the SO group, leading to similar changes in the triene:tetraene ratio (T:T). Genetic polymorphisms were frequently observed in patients presenting extreme arachidonic acid values in both groups.

conclusionsThe use of an 80% OO/20% SO ILE is well tolerated, safe, and does not increase the risk of EFAD in pediatric patients. The assessment of EFAD should not only consider the T:T but also the complete FA profile and genetic polymorphisms. TRIAL IDENTIFICATION NUMBER: Trial Identification Number and URL: NCT04555044, https://clinicaltrials.gov/study/NCT04555044?term=NCT04555044&rank=1.

Indexed as

Fat Emulsions, IntravenousFatty Acids, EssentialOlive OilParenteral NutritionPolymorphism, GeneticArachidonic AcidChild, PreschoolDouble-Blind MethodFatty Acid DesaturasesFemaleHumansInfantInfant, NewbornInfant, PrematureLinoleic AcidMaleArachidonic AcidFat Emulsions, IntravenousFatty Acid DesaturasesFatty Acids, EssentialLinoleic AcidOlive OilSoybean Oilfat emulsionsparenteral nutritionpremature infants

Identifiers

PMID40415417
PMCPMC12314573

What Socratic holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.