NCT04259008

Safety of Manganese Restriction in Neonatal Parenteral Nutrition

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Infant, Newborn, Disease

Interventions

Type	Name	Description
OTHER	Manganese omission	Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.
OTHER	5 mCg/kg/day manganese from "Multitrace-4 Neonatal."	5 mCg/kg/day manganese from "Multitrace-4 Neonatal."

Timeline

• Start date: 2020-06-11
• Primary completion: 2021-07-22
• Completion: 2021-07-22
• First posted: 2020-02-06
• Last updated: 2021-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study