Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Status Completed

Clinical Trial Summary

Participants will be <= 32 weeks gestational age (GA) neonates randomized to parenteral nutrition (PN) prepared with standard dose trace elements or to PN prepared with standard trace elements minus manganese.

Clinical Trial Description

Very preterm neonates <= 32+6 weeks GA receiving PN will be randomized to receive their PN prepared with standard trace elements containing 5 mcg/kg/day of manganese, or to PN prepared with no added manganese. Randomization assignment will be double masked. All participants will have whole blood manganese measurements at baseline, at 2 weeks of postnatal age, and at 8 weeks postnatal age. Because manganese is present as a contaminant in many of the ingredients used to prepare neonatal PN, this study hypothesizes that neonates randomized to no added manganese in their PN will maintain whole blood manganese concentrations above the lower limit of normal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04259008
Study type	Interventional
Source	Sharp HealthCare
Contact
Status	Completed
Phase	Phase 4
Start date	June 11, 2020
Completion date	July 22, 2021

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