Dataset Information

A Mixed Lipid Emulsion for Prevention of Parenteral Nutrition Associated Cholestasis in Extremely Low Birth Weight Infants: A Randomized Clinical Trial.

ABSTRACT: OBJECTIVES:To examine whether a mixed lipid emulsion reduces the incidence of parenteral nutrition associated cholestasis (PNAC) in extremely low birth weight (ELBW, <1000 g) infants. STUDY DESIGN:This double-blind randomized trial of 230 ELBW infants (June 2012-October 2015) was performed at a single level IV neonatal intensive care unit. Patients received either a mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil-(intervention) or a soybean oil-based lipid emulsion (control) for parenteral nutrition. The primary outcome measure was PNAC (conjugated bilirubin?>1.5?mg/dL [25?µmol/L] at 2 consecutive measurements). The study was powered to detect a reduction of PNAC from 25% to 10%. RESULTS:Reasons for noneligibility of 274 infants screened were refusal to participate (n?=?16), death (n?=?10), withdrawal of treatment (n?=?5), higher order multiples (n?=?9), and parents not available for consent (n?=?4). Intention to treat analysis was carried out in 223 infants (7 infants excluded after randomization). Parenteral nutrition associated cholestasis was 11 of 110 (10.1%) in the intervention and 18 of 113 (15.9%) in the control group (P?=?.20). Multivariable analyses showed no statistically significant difference in the intention to treat (aOR 0.428, 95% CI 0.155-1.187; P?=?.10) or per protocol population (aOR 0.457, 95% CI 0.155-1.347; P?=?.16). There was no statistically significant effect on any other neonatal morbidity. CONCLUSIONS:The incidence of parenteral nutrition associated cholestasis was not significantly reduced using a mixed lipid emulsion in ELBW infants. TRIAL REGISTRATION:ClinicalTrials.govNCT01585935.

SUBMITTER: Repa A

PROVIDER: S-EPMC5830079 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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A Mixed Lipid Emulsion for Prevention of Parenteral Nutrition Associated Cholestasis in Extremely Low Birth Weight Infants: A Randomized Clinical Trial.

Repa Andreas A Binder Christoph C Thanhaeuser Margarita M Kreissl Alexandra A Pablik Eleonore E Huber-Dangl Mercedes M Berger Angelika A Haiden Nadja N

The Journal of pediatrics 20171218

<h4>Objectives</h4>To examine whether a mixed lipid emulsion reduces the incidence of parenteral nutrition associated cholestasis (PNAC) in extremely low birth weight (ELBW, <1000 g) infants.<h4>Study design</h4>This double-blind randomized trial of 230 ELBW infants (June 2012-October 2015) was performed at a single level IV neonatal intensive care unit. Patients received either a mixed lipid emulsion composed of soybean oil, medium chain triglycerides, olive oil, and fish oil-(intervention) or ...[more]

PMID: 29269199

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Project description:BackgroundParenteral nutrition associated cholestasis (PNAC) is a frequently observed pathology in extremely low birth weight (ELBW) infants. Its pathogenesis is determined by the composition and duration of parenteral nutrition (PN) as well as the tolerance of enteral feeds (EF). "Aggressive" nutrition is increasingly used in ELBW infants to improve postnatal growth. Little is known about the effect of "aggressive" nutrition on the incidence of PNAC. We analyzed the influence of implementing an "aggressive" nutritional regimen on the incidence of PNAC and growth in a cohort of ELBW infants.MethodsELBW infants were nourished using a "conservative" (2005-6; n = 77) or "aggressive" (2007-9; n = 85) nutritional regimen that differed in the composition of PN after birth as well as the composition and timing of advancement of EFs. We analyzed the incidence of PNAC (conjugated bilirubin > 1.5 mg/dl (25 µmol/l)) corrected for confounders of cholestasis (i.e., NEC and/or gastrointestinal surgery, sepsis, birth weight, Z-score of birth weight, time on PN and male sex), growth until discharge (as the most important secondary outcome) and neonatal morbidities.ResultsThe incidence of PNAC was significantly lower during the period of "aggressive" vs. "conservative "nutrition (27% vs. 46%, P < 0.05; adjusted OR 0.275 [0.116-0.651], P < 0.01). Body weight (+411g), head circumference (+1 cm) and length (+1 cm) at discharge were significantly higher. Extra-uterine growth failure (defined as a Z-score difference from birth to discharge lower than -1) was significantly reduced for body weight (85% vs. 35%), head circumference (77% vs. 45%) and length (85% vs. 65%) (P < 0.05). The body mass index (BMI) at discharge was significantly higher (11.1 vs. 12.4) using "aggressive" nutrition and growth became more proportionate with significantly less infants being discharged below the 10th BMI percentile (44% vs. 9%), while the percentage of infants discharged over the 90th BMI percentile (3% vs. 5%) did not significantly increase.Discussion"Aggressive" nutrition of ELBW infants was associated with a significant decrease of PNAC and marked improvement of postnatal growth.

Project description:Preterm birth survivors are at a higher risk of growth and developmental disabilities compared to their term counterparts. Development of strategies to lower the complications of preterm birth forms the rising need of the hour. Appropriate nutrition is essential for the growth and development of preterm infants. Early administration of optimal nutrition to preterm birth survivors lowers the risk of adverse health outcomes and improves cognition in adulthood. A group of neonatologists, pediatricians, and nutrition experts convened to discuss and frame evidence-based recommendations for optimizing nutrition in preterm low birth weight (LBW) infants. The following were the primary recommendations of the panel: (1) enteral feeding is safe and may be preferred to parenteral nutrition due to the complications associated with the latter; however, parenteral nutrition may be a useful adjunct to enteral feeding in some critical cases; (2) early, fast, or continuous enteral feeding yields better outcomes compared to late, slow, or intermittent feeding, respectively; (3) routine use of nasogastric tubes is not advisable; (4) preterm infants can be fed while on ventilator or continuous positive airway pressure; (5) routine evaluation of gastric residuals and abdominal girth should be avoided; (6) expressed breast milk (EBM) is the first choice for feeding preterm infants due to its beneficial effects on cardiovascular, neurological, bone health, and growth outcomes; the second choice is donor pasteurized human milk; (7) EBM or donor milk may be fortified with human milk fortifiers, without increasing the osmolality of the milk, to meet the high protein requirements of preterm infants; (8) standard fortification is effective and safe but does not fulfill the high protein needs; (9) use of targeted and adjustable fortification, where possible, helps provide optimal nutrition; (10) optimizing weight gain in preterm infants prevents long-term cardiovascular complications; (11) checking for optimal weight and sucking/swallowing ability is essential prior to discharge of preterm infants; and (12) appropriate counseling and regular follow-up and monitoring after discharge will help achieve better long-term health outcomes. This consensus summary serves as a useful guide to clinicians in addressing the challenges and providing optimal nutrition to preterm LBW infants.

Dataset Information

A Mixed Lipid Emulsion for Prevention of Parenteral Nutrition Associated Cholestasis in Extremely Low Birth Weight Infants: A Randomized Clinical Trial.

Publications

A Mixed Lipid Emulsion for Prevention of Parenteral Nutrition Associated Cholestasis in Extremely Low Birth Weight Infants: A Randomized Clinical Trial.

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