Safety of manganese restriction

Clinical trial: Safety of manganese restriction in neonatal parenteral nutrition

Primary investigator: Jason Sauberan

Research coordinator: Jason Sauberan

About this trial

Preterm babies in the NICU born less than 33 weeks gestational age routinely receive parenteral nutrition (PN) for the first two to three weeks after birth. This intravenous nutrition contains many essential nutrients, including the trace element manganese. However, the amount of manganese received is more than they need, due to limited options for trace elements products appropriate for very small preterm babies.

As excessive manganese may be harmful to a baby's developing brain, we think a good idea is not adding any manganese to PN. Maternal manganese deficiency is very rare, so most babies are born with enough manganese in their bodies. Plus, manganese is present as a contaminant in most of the ingredients used to make PN each day, so a preterm baby is getting a small but adequate amount daily, even when it's not added. There is also manganese in breastmilk and preterm formula, which babies in the NICU are fed by a tube, so they will get some manganese that way and should not need extra.

Our group, and others, have studied the amount of manganese contamination in our PN solutions, and we think this plan will work, but we need to study it to be sure. To do so, we will randomly assign preterm babies to receive their normal PN with or without manganese, and then test their blood for manganese three times over the course of their hospitalization in the NICU.

The results of this study will be used to encourage U.S. nutrition manufacturers to develop trace element products that are more appropriate for preterm neonates than what is currently available.

To learn more about this study, visit ClinicalTrials.gov.

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For more information about the Neonatal Research Institute or to learn more about our clinical trials, send us an email or call 858-939-4112.