Evidence map›Paper›PMID 23894176›Full record

Trial reportJPEN. Journal of parenteral and enteral nutrition2014

Pediatric intestinal failure-associated liver disease is reversed with 6 months of intravenous fish oil.

Kara L Calkins, James C Y Dunn, Stephen B Shew, Laurie Reyen, Douglas G Farmer, Sherin U Devaskar, Robert S Venick

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in JPEN. Journal of parenteral and enteral nutrition, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00969332 (Omegaven and Parenteral Nutrition Associated Cholestasis), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT00969332 phase2terminatednot on this map

Omegaven and Parenteral Nutrition Associated Cholestasis

TypeinterventionalSponsorUniversity of California, Los AngelesRan2009 to 2019Enrolled62ConditionsCholestasisArmsOmegaven
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Lipid emulsions for parenterally fed term and late preterm infants.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. ESPEN guideline on clinical nutrition in liver disease.Clinical nutrition (Edinburgh, Scotland) · 2019
    Guideline
  3. Pooled it
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Observational
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Observational
  17. Review
  18. Review
  19. Article
  20. 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 1 institution in 1 country.

Kara L CalkinsDepartment of Pediatrics, Division of Neonatology and Developmental Biology, Neonatal Research Center KCalkins@mednet.ucla.edu.
James C Y DunnDepartment of Surgery, Division of Pediatric Surgery.
Stephen B ShewDepartment of Surgery, Division of Pediatric Surgery.
Laurie ReyenDepartment of Nursing.
Douglas G FarmerDepartment of Surgery.
Sherin U DevaskarDepartment of Pediatrics, Division of Neonatology and Developmental Biology, Neonatal Research Center.
Robert S VenickDepartment of Surgery Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition, David Geffen School of Medicine, Mattel Children's Hospital UCLA, University of California, Los Angeles.
Mattel Children's Hospital · US

Funding

UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
ZDV &3TC NEVIRAPINE COMBINATION THERAPY IN HIV 1 INFECTED INFANTS &M01RR000865 · NCRR · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI WASHINGTON, ARNOLD E. · 1985 to 2011
$43.4M
Prenatal Metabolic Programming of the OffspringR01HD041230 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DEVASKAR, SHERIN U · 2001 to 2019
$5.2M
Building Interdisciplinary Research Careers in Women's Health (BIRCWH) CenterK12HD001400 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CHAUDHURI, GAUTAM · 2000 to 2009
$4.2M
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 UL1 TR000124NCATS NIH HHS UL1TR000124NCRR NIH HHS M01 RR000865NCRR NIH HHS M01-RR00865NICHD NIH HHS K08 HD052885NICHD NIH HHS K08HD052885NICHD NIH HHS K12HD00140NICHD NIH HHS K12 HD001400NICHD NIH HHS R01 HD041230PHS HHS T32G075776
6 · The paper itself

Abstract

backgroundStudies have suggested that when intravenous (IV) soybean oil (SO) is replaced with fish oil (FO), direct hyperbilirubinemia is more likely to resolve. The necessary duration of FO has not been established. This study seeks to determine if 24 weeks of FO is an effective and safe therapy for intestinal failure-associated liver disease (IFALD). MATERIALS AND

methodsThis is a clinical trial using patients with IFALD between the ages of 2 weeks and 18 years. SO was replaced with FO (1 g/kg/d) in 10 patients who were receiving most of their calories from parenteral nutrition (PN). Patients were compared with 20 historic controls receiving SO. SO for both groups was prescribed by the primary medical team at variable doses. The primary outcome was time to reversal of cholestasis. Secondary outcomes were death, transplant, and full enteral feeds. Safety measurements included growth, essential fatty acid deficiency, and laboratory markers to assess bleeding risk.

resultsThe Kaplan-Meier method estimated that 75% in the FO group would experience resolution of cholestasis by 17 weeks vs 6% in the SO group (P < .0001). When compared with the SO group, the FO group had decreased serum direct bilirubin concentrations at weeks 8 (P = .03) and 12, 16, 20, and 24 weeks (P < .0001). Although length z score at the end of the study increased in the FO group compared with baseline (P = .03), there were no significant differences in other outcomes.

conclusionsA limited duration of FO appears to be safe and effective in reversing IFALD.

Indexed as

Administration, IntravenousBilirubinCholestasisFat Emulsions, IntravenousFemaleFish OilsHumansInfantIntestinal DiseasesLiver DiseasesLiver Function TestsMaleParenteral NutritionProspective StudiesSoybean OilTreatment OutcomeBilirubinFat Emulsions, IntravenousFish OilsSoybean Oilcholestasisfish oilprematurityshort bowel syndromesoybean oil

Identifiers

PMID23894176
PMCPMC4254367
OpenAlexW2106454717

What OpenQuestion holds

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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 OpenQuestion graph.