169 - Manganese omission in preterm neonatal parenteral nutrition

Poster Number: 169
Publication Number: 169.233

Jason B. Sauberan, Neonatal Research Institute, San Diego, CA, United States; Anup Katheria, Sharp Mary Birch Hospital for Women & Newborns, SAN DIEGO, CA, United States

Background: Standard manganese (Mn) dosing in neonatal parenteral nutrition (PN) is physiologically excessive and may be neurotoxic to developing subcortical nerve structures. Very preterm neonates are at high risk of excessive Mn exposure due to their routine prolonged PN requirement. Since Mn is known to be present as a contaminant in many ingredients used to prepare PN, a plausible intervention to reduce the risk of harm from excessive Mn exposure is not voluntarily adding Mn during PN preparation.

Objective: To test the feasibility and safety of a no-added-Mn approach to PN preparation in very preterm neonates.

Design/Methods: Neonates less than 32 weeks gestational age were randomized to receive test PN prepared without adding Mn, or control PN prepared with standard Mn 5 mcg/kg/day. Randomization assignment was double masked and provided as the participant’s daily standard of care PN beginning with the first PN and continued until PN was discontinued by their NICU provider. Whole blood Mn levels were measured at baseline, 2 weeks, and 8 weeks postnatal age. Standard growth parameters were collected prospectively from the electronic health record. Withdrawal criteria were abnormal baseline Mn level ( < 4 mcg/L, > 50 mcg/L), unable to complete blood sampling schedule, or postnatal cholestasis. Student’s t-Test was used to compare outcomes between the two groups.

Results: Twenty-six participants were enrolled. Two were withdrawn from the intervention group due to death and surgical transfer. Five were withdrawn from the control group due to death (n=2), cholestasis (n=2), and insufficient sample quantity. Mean postnatal day of blood sampling after baseline was 18 and 60 in the intervention group, and 17 and 56 in the control group. Mn levels and the percent change in Mn levels are shown in Table 1. Mn levels remained within normal limits throughout the study period. Nutrition and growth outcomes are shown in Table 2. None of the differences between groups was statistically significant (p value < 0.05).Conclusion(s): In our study population, the provision of no-added-Mn PN in routine care was feasible and not associated with altered Mn blood levels or growth compared to standard PN. Very preterm neonates are born with sufficient Mn blood levels and can maintain sufficient levels without adding any Mn to their PN. This observed Mn level maintenance may be due to Mn being silently provided through PN ingredient contamination. We recommend future studies focus on developing and clinically testing an investigational Mn-free parenteral trace element combination product in very preterm neonates.
Whole blood manganese, mcg/LValues are median (range), unless otherwise specified
Nutrition and growth outcomesValues are median (range), unless otherwise specified