Manganese restriction in parenteral nutrition for preterm neonates: A pilot randomized controlled trial.

Background: Manganese (Mn) is present in many parenteral nutrition (PN) ingredients, presumably as a contaminant during ingredient manufacturing. Exposure to Mn in PN may have negative health consequences in preterm neonates. The purpose of this study was to test the feasibility and safety of not adding supplemental Mn to PN prepared for extremely preterm and very preterm neonates compared with standard Mn supplementation.

Methods: Neonates <32 weeks' gestational age were randomized on postnatal day 1 to receive test PN prepared without adding Mn or standard PN prepared with Mn 5 mcg/kg/day using a commercially available neonatal multitrace element product. Randomization assignment was blinded to the clinical team. Whole blood Mn levels were measured at baseline, 2 weeks, and 8 weeks postnatal age. Growth parameters and nutrition intake were also collected.

Results: Twenty-six participants were enrolled and nineteen completed the trial. The median duration of PN was 11 days in the no Mn group and 12 days in the standard Mn group. Whole blood Mn levels were not significantly different between the two groups at any time point. Growth and nutrition outcomes were also not significantly different between the two groups.

Conclusions: The provision of no-added-Mn PN in routine care was feasible and did not alter Mn blood levels or growth in the first 8 weeks of postnatal age compared with standard PN.