Evidence map›Paper›PMID 26024828›Full record

Trial reportJPEN. Journal of parenteral and enteral nutrition2017

Low-Dose Parenteral Soybean Oil for the Prevention of Parenteral Nutrition-Associated Liver Disease in Neonates With Gastrointestinal Disorders.

Kara L Calkins, Thomas Havranek, Lorraine I Kelley-Quon, Laura Cerny, Martiniano Flores, Tristan Grogan, Stephen B Shew

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JPEN. Journal of parenteral and enteral nutrition, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 13% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Lipid emulsions for parenterally fed term and late preterm infants.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Observational
  8. Review
  9. Review
  10. Review
  11. Article
  12. Observational
  13. Article
  14. 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

7 authors at 2 institutions in 1 country.

Kara L Calkins1 David Geffen School of Medicine, University of California, Los Angeles, and Mattel Children's Hospital at UCLA, Department of Pediatrics, Division of Neonatology and Developmental Biology, Neonatal Research Center of the UCLA Children's Discovery and Innovation Institute, Los Angeles, California, USA.
Thomas Havranek2 Department of Pediatrics, Division of Neonatology, St Louis University School of Medicine, Cardinal Glennon Children's Hospital, St Louis, Missouri, USA.
Lorraine I Kelley-Quon4 Department of Surgery, Division of General Surgery, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
Laura Cerny2 Department of Pediatrics, Division of Neonatology, St Louis University School of Medicine, Cardinal Glennon Children's Hospital, St Louis, Missouri, USA.
Martiniano Flores5 Department of Biostatistics, Fielding School of Public Health, University of California, Los Angeles, California, USA.
Tristan Grogan6 Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
Stephen B Shew7 Department of Surgery, Division of Pediatric Surgery, David Geffen School of Medicine, University of California, Los Angeles, California, USA.
University of California, Los Angeles · USCardinal Glennon Children’s Medical Center · US

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
The Effect of Nanoparticle Encapsulated Resveratrol on Treatment of PeriodontitisKL2TR001882 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Elizabeta Nemeth · 2016 to 2026
$13.1M
UCLA Clinical and Translational Science InstituteKL2TR000122 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$4.5M
Building Interdisciplinary Research Careers in Women's Health (BIRCWH) CenterK12HD001400 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CHAUDHURI, GAUTAM · 2000 to 2009
$4.2M
UCLA Clinical Pharmacology Training ProgramT32GM075776 · NIGMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LEUCHTER, ANDREW F · 2006 to 2015
$2.1M
Effect of cysteine on glutathione production in critically ill neonatesK08HD052885 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI SHEW, STEPHEN · 2006 to 2010
$609k
NCATS NIH HHS KL2 TR000122NCATS NIH HHS KL2 TR001882NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1 TR001881NICHD NIH HHS K08 HD052885NICHD NIH HHS K12 HD001400NIGMS NIH HHS T32 GM075776
6 · The paper itself

Abstract

backgroundNeonates with gastrointestinal disorders (GDs) are at high risk for parenteral nutrition-associated liver disease (PNALD). Soybean-based intravenous lipid emulsions (S-ILE) have been associated with PNALD. This study's objective was to determine if a lower dose compared with a higher dose of S-ILE prevents cholestasis without compromising growth. MATERIALS AND

methodsThis multicenter randomized controlled pilot study enrolled patients with GDs who were ≤5 days of age to a low dose (~1 g/kg/d) (LOW) or control dose of S-ILE (~3 g/kg/d) (CON). The primary outcome was cholestasis (direct bilirubin [DB] >2 mg/dL) after the first 7 days of age. Secondary outcomes included growth, PN duration, and late-onset sepsis.

resultsBaseline characteristics were similar between the LOW (n = 20) and CON groups (n = 16). When the LOW group was compared with the CON group, there was no difference in cholestasis (30% vs 38%, P = .7) or secondary outcomes. However, mean ± SE DB rate of change over the first 8 weeks (0.07 ± 0.04 vs 0.3 ± 0.09 mg/dL/wk, P = .01) and entire study (0.008 ± 0.03 vs 0.2 ± 0.07 mg/dL/wk, P = .02) was lower in the LOW group compared with the CON group.

conclusionIn neonates with GDs who received a lower dose of S-ILE, DB increased at a slower rate in comparison to neonates who received a higher dose of S-ILE. Growth was comparable between the groups. This study demonstrates a need for a larger, randomized controlled trial comparing 2 different S-ILE doses for cholestasis prevention in neonates at risk for PNALD.

Indexed as

BilirubinCholestasisDose-Response Relationship, DrugFat Emulsions, IntravenousFeasibility StudiesFemaleGastrointestinal DiseasesHumansInfantInfant, NewbornLiver DiseasesMaleParenteral NutritionPilot ProjectsSoybean OilTreatment OutcomeBilirubinFat Emulsions, IntravenousSoybean Oilcholestasisgastrointestinal disordersneonatesparenteral nutritionsoybean oil

Identifiers

PMID26024828
PMCPMC4663189
OpenAlexW432621628

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.