Elsevier

The Journal of Pediatrics

Volume 161, Issue 2, August 2012, Pages 229-233.e1
The Journal of Pediatrics

Original Article
Randomized Controlled Trial of Early Parenteral Nutrition Cycling to Prevent Cholestasis in Very Low Birth Weight Infants

Originally presented at platform sessions at the Pediatric Academic Societies annual meeting, Denver, Colorado, May 3, 2011, and the Eastern Society of Pediatric Research annual meeting, Philadelphia, Pennsylvania, March 26, 2011.
https://doi.org/10.1016/j.jpeds.2012.02.003Get rights and content

Objectives

To compare the incidence of cholestasis in very low birth weight infants receiving cycled versus continuous parenteral nutrition, and to determine factors that predispose to parenteral nutrition–associated cholestasis (PNAC).

Study design

Preterm infants weighing ≤1250 g (n = 70) at birth were randomly assigned within the first 5 postnatal days to either cycle (n = 34) or continuous (n = 36) parenteral nutrition. Liver function tests were obtained at baseline, and sequentially thereafter. Cholestasis was defined as direct bilirubin >2 mg/dL. Infants with major congenital anomalies, congenital hepatic disease, clinically apparent congenital viral infection, and those who required major abdominal surgery were excluded.

Results

The incidence of PNAC was similar in the 2 groups (cycle 32% vs continuous 31%; P = 1.0). Bilirubin and transaminases were similar in both groups by repeated measures of ANOVA. Gestational age, birth weight, and Apgar scores were significantly lower, and Clinical Risk Index for Babies II scores were significantly higher in infants who developed PNAC. Using backward selection logistic regression, bronchopulmonary dysplasia, duration of parenteral nutrition, and days to full enteral nutrition emerged as factors independently associated with PNAC.

Conclusions

Early prophylactic parenteral nutrition cycling in very low birth weight infants in this study did not reduce cholestasis. Time to full feedings is a significant predictor for PNAC in very low birth weight infants. Preterm infants with bronchopulmonary dysplasia are more likely to have PNAC as a comorbidity. The Clinical Risk Index for Babies II score may help identify those preterm infants who might benefit from future prospective prevention trials.

Section snippets

Methods

This prospective randomized controlled trial was conducted in a level 3 neonatal intensive care unit (NICU) with all inborn patients from an inner city population. The study was approved by the hospital's Institutional Review Board. Inclusion criteria were birth weight ≤1250 g and enrollment within the first 5 days after birth. Infants with major congenital anomalies, congenital hepatic disease, and clinically apparent congenital viral infection were excluded.

Informed consent was obtained

Results

A total of 83 patients were enrolled in the study between November 2007 and July 2010; 70 patients (34 in the cycle parenteral nutrition group and 36 in the continuous parenteral nutrition group) completed the study protocol. Thirteen patients were excluded from the final analysis because of transfer to a children's hospital for various reasons (Figure; available at www.jpeds.com).

Gestational age (22-30 weeks), birth weight (420-1250 g), sex, Apgar score, and CRIB II score were similar in the

Discussion

In this study, early prophylactic cycling of parenteral nutrition (20 hours on and 4 hours off) did not reduce the incidence of PNAC in VLBW infants. The biochemical markers of hepatic dysfunction, including direct bilirubin, transaminase, and GGT levels, were not different between the cycle and continuous parenteral nutrition groups. Our findings show that postnatal factors, such as time to full feedings and prolonged exposure to parenteral nutrition, are independent risk factors for PNAC.

References (21)

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    This is especially the case with lower gestational ages or at higher infusion rates. Besides, interruption of PN in neonates could result in higher infection rate, possibly due to increased line handling [91,92]. A retrospective analysis of PN cycling in both preterm and term neonates with gastrointestinal disorders requiring surgical intervention showed that prophylactic daily discontinuous PN infusion could not prevent a rise in conjugated bilirubin concentrations [93].

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    Besides prematurity and prolonged TPN use, other risk factors for IFALD include lack of enteral nutrition, multiple operative procedures, sepsis or inflammation, and possibly also nutrient deficiencies or toxicities associated with other components in lipid PN [140,141]. Preventative/treatment measures for IFALD may include cycling PN, feed advancement, prevention and aggressive treatment of sepsis, lipid reduction to ≤1 g/kg/d, altering the lipid being used in PN (see below), elimination of hepatotoxic medications, reduction of bacterial overgrowth, use of the bile acid ursodiol, reduction of transfusions and minimizing surgical procedures if possible [137,142–151], although the evidence in favor of some of these is weak [152]. Whilst IFALD/cholestasis may be reversed with elimination/reduction of lipids, cholestasis may be progressive whilst on PN.

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The authors declare no conflicts of interest.

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