title: Preliminary findings of long-term neurodevelopmental outcomes of infants treated with intravenous fat emulsion reduction for the management of parenteral nutrition-associated cholestasis.
abstract: BACKGROUND
  Parenteral nutrition-associated cholestasis (PNAC) is linked with the administration of soybean-based intravenous fat emulsion (IVFE). IVFE reduction (IFER) may be an effective management strategy for PNAC; however, long-term associated neurodevelopmental outcomes (NDOs) for infants undergoing IFER have not been measured previously. This single-institution, prospective study examined the risk for negative NDOs and key predictors of NDOs associated with IFER.
  
  
  METHODS
  Patients (2-5 years) treated with soybean-based IFER as neonates underwent NDO measurements, including Ages and Stages Questionnaires-3 (ASQ-3), Parents' Evaluations of Developmental Status (PEDS), and Behavior Assessment System for Children, Second Edition Preschool, Parent (BASC-2 PRS-P). The relationship between NDOs and predictive variables was evaluated.
  
  
  RESULTS
  A total of 25 children had a complete PEDS survey, and 17 were found to be "not at risk." The BASC-2 PRS-P evaluation (n = 18 patients) showed that all 4 composite domains fell within the normative developmental range, and 67%-89% of patients were observed to be "typically developing." For the primary outcome measure, ASQ-3, 82.4%-94.4% of patients were "not at risk." Logistical regression analyses were performed to examine risk factors contributing to negative NDOs. Of children completing all NDO studies, IFER-related variables (eg, development of essential fatty acid deficiency, duration of IFER, and mean IVFE dose) were not found to be predictors of adverse NDOs.
  
  
  CONCLUSIONS
  This study represents the first report of NDOs in pediatric patients treated with IFER. IFER-treated patients score within the normative range most of the time. IFER-related variables were not found to be associated with negative NDOs. The results set the stage for a larger, multicenter, prospective study.
authors.affiliation: Department of Clinical, Social and Administrative Sciences, University of Michigan College of Pharmacy, Ann Arbor Department of Pharmacy Services, University of Michigan Health System, Ann Arbor allison.blackmer@ucdenver.edu.
authors.forename: Allison B
authors.initials: AB
authors.lastname: Blackmer
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Michigan Health System, Ann Arbor.
authors.forename: Seth
authors.initials: S
authors.lastname: Warschausky
authors.affiliation: Department of Surgery, C. S. Mott Children's Hospital, University of Michigan, Ann Arbor.
authors.forename: Sabina
authors.initials: S
authors.lastname: Siddiqui
authors.affiliation: School of Public Health, University of Michigan, Ann Arbor.
authors.forename: Kathleen B
authors.initials: KB
authors.lastname: Welch
authors.affiliation: College of Pharmacy, University of Michigan, Ann Arbor.
authors.forename: Karolyn
authors.initials: K
authors.lastname: Horn
authors.affiliation: College of Pharmacy, University of Michigan, Ann Arbor.
authors.forename: Ashley
authors.initials: A
authors.lastname: Wester
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Michigan Health System, Ann Arbor.
authors.forename: Micah
authors.initials: M
authors.lastname: Warschausky
authors.affiliation: Department of Surgery, C. S. Mott Children's Hospital, University of Michigan, Ann Arbor.
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Teitelbaum
mesh_terms: D002490:Central Nervous System / Q000503:physiopathology*; D002675:Child, Preschool; D002779:Cholestasis / Q000209:etiology / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007223:Infant; D016015:Logistic Models; D008297:Male; D010288:Parenteral Nutrition / Q000009:adverse effects*; D011446:Prospective Studies; D012959:Socioeconomic Factors; D013024:Soybean Oil / Q000008:administration & dosage / Q000009:adverse effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D005217:Fat Emulsions, Intravenous; D013024:Soybean Oil
keywords: cholestasis; infants; lipid minimization; neurodevelopment