Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Sharp HealthCare26 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Infant, Newborn, Disease

Interventions

Manganese omissionOTHER

Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.

5 mCg/kg/day manganese from "Multitrace-4 Neonatal."OTHER

5 mCg/kg/day manganese from "Multitrace-4 Neonatal."

Eligibility

Sex: ALLMax age: 1 Day

Medical Language ↔ Plain English

Inclusion Criteria: * Inborn admissions to the SHARP Mary Birch Hospital for Women and Newborns neonatal intensive care unit. * Less than or equal to 32+6 weeks gestational age. * Initiated on parenteral nutrition as decided by their attending neonatologist. Exclusion Criteria: * Continuous exposure to routine care PN containing standard trace element for ≥ 4 hours. * Congenital liver disease. * Moribund status or imminent death. * Any condition that in the judgment of the investigator or attending physician provider precludes participation because it could affect subject safety. * Lack or refusal of informed consent

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

Outcomes

Primary Outcomes

Whole Blood Manganese

concentration of manganese in blood

Time frame: Baseline

Whole Blood Manganese

concentration of manganese in blood

Time frame: 2 weeks of age

Whole Blood Manganese

concentration of manganese in blood

Time frame: 8 weeks of age

Data from ClinicalTrials.gov

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