Evidence map›Paper›PMID 24963025›Full record

Trial reportJPEN. Journal of parenteral and enteral nutrition2016

Low-Dose Intravenous Soybean Oil Emulsion for Prevention of Cholestasis in Preterm Neonates.

Orly L Levit, Kara L Calkins, L Caroline Gibson, Lorraine Kelley-Quon, Daniel T Robinson, David A Elashoff, Tristan R Grogan, Ning Li, Matthew J Bizzarro, Richard A Ehrenkranz

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JPEN. Journal of parenteral and enteral nutrition, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
6.2field-weighted citation impact, top 3% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Short Bowel Syndrome.Current treatment options in pediatrics · 2019
    Article
  14. Article
  15. Intravenous Fat Emulsion Formulations for the Adult and Pediatric Patient: Understanding the Differences.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2016
    Review
  16. Article
  17. Review
  18. 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

10 authors at 3 institutions in 1 country.

Orly L LevitDepartment of Pediatrics, Yale University School of Medicine, New Haven, Connecticut orly.levit@yale.edu.
Kara L CalkinsDepartment of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California.
L Caroline GibsonDepartment of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, California.
Lorraine Kelley-QuonDepartment of Surgery, David Geffen School of Medicine, University of California, Los Angeles, California.
Daniel T RobinsonFeinberg School of Medicine, Northwestern University, Chicago, Illinois.
David A ElashoffDepartment of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California.
Tristan R GroganDepartment of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, California.
Ning LiDepartment of Biomathematics, University of California, Los Angeles, California.
Matthew J BizzarroDepartment of Pediatrics, Yale University School of Medicine, New Haven, Connecticut.
Richard A EhrenkranzDepartment of Pediatrics, Yale University School of Medicine, New Haven, Connecticut.
University of California, Los Angeles · USYale University · USNorthwestern University · US

Funding

UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
UCLA Child Health Research Career Development AwardK12HD034610 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DEVASKAR, SHERIN U · 2002 to 2017
$6.6M
Building Interdisciplinary Research Careers in Women's Health (BIRCWH) CenterK12HD001400 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CHAUDHURI, GAUTAM · 2000 to 2009
$4.2M
RESEARCH IN PERINATAL MEDICINET32HD007094 · NICHD · YALE UNIVERSITY · PI GALLAGHER, PATRICK G · 1985 to 2015
$3.6M
UCLA Clinical Pharmacology Training ProgramT32GM075776 · NIGMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LEUCHTER, ANDREW F · 2006 to 2015
$2.1M
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1TR000124NICHD NIH HHS K12HD00140NICHD NIH HHS K12 HD001400NICHD NIH HHS K12 HD034610NICHD NIH HHS T32 HD007094NIGMS NIH HHS T32 GM075776PHS HHS T32G075776-6
6 · The paper itself

Abstract

backgroundPremature infants depend on intravenous fat emulsions to supply essential fatty acids and calories. The dose of soybean-based intravenous fat emulsions (S-IFE) has been associated with parenteral nutrition (PN)-associated liver disease. This study's purpose was to determine if low-dose S-IFE is a safe and effective preventive strategy for cholestasis in preterm neonates. MATERIALS AND

methodsThis is a multicenter randomized controlled trial in infants with a gestational age (GA) ≤29 weeks. Patients <48 hours of life were randomized to receive a low (1 g/kg/d) or control dose (approximately 3 g/kg/d) of S-IFE. The primary outcome was cholestasis, defined as a direct bilirubin ≥15% of the total bilirubin at 28 days of life (DOL) or full enteral feeds, whichever was later, after 14 days of PN. Secondary outcomes included growth, length of hospital stay, death, and major neonatal morbidities.

resultsIn total, 136 neonates (67 and 69 in the low and control groups, respectively) were enrolled. Baseline characteristics were similar for the 2 groups. When the low group was compared with the control group, there was no difference in the primary outcome (69% vs 63%; 95% confidence interval, -0.1 to 0.22; P = .45). While the low group received less S-IFE and total calories over time compared with the control group (P < .001 and P = .03, respectively), weight, length, and head circumference at 28 DOL, discharge, and over time were not different (P > .2 for all).

conclusionCompared with the control dose, low-dose S-IFE was not associated with a reduction in cholestasis or growth.

Indexed as

Administration, IntravenousBilirubinCholestasisDose-Response Relationship, DrugFat Emulsions, IntravenousGestational AgeHumansInfant, NewbornInfant, PrematureLength of StaySoybean OilTreatment OutcomeBilirubinFat Emulsions, IntravenousSoybean Oilgrowthparenteral nutrition–associated liver diseaseprematurity

Identifiers

PMID24963025
PMCPMC4537394
OpenAlexW2081743324

What OpenQuestion holds

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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.