Safety of Manganese Restriction in Neonatal Parenteral Nutrition

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.

Study Overview

• Status: Completed
• Conditions: Infant, Newborn, Disease
• Intervention / Treatment: Other: 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."; Other: Manganese omission

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard neonatal trace elements; Parenteral nutrition containing 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."	Other: 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."; 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
Experimental: Manganese-free neonatal trace elements; Parenteral nutrition containing the same trace element doses as "Multitrace-4 Neonatal" minus manganese.	Other: Manganese omission; Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole Blood Manganese	concentration of manganese in blood	Baseline
Whole Blood Manganese	concentration of manganese in blood	2 weeks of age
Whole Blood Manganese	concentration of manganese in blood	8 weeks of age

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Collaborators: Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Jason B Sauberan, PharmD, Sharp HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): July 22, 2021
• Study Completion (Actual): July 22, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: manganese, parenteral nutrition, neonate, preterm, safety
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Physiological Effects of Drugs; Trace Elements; Micronutrients; Manganese
• Other Study ID Numbers: 2001902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately after publication
• IPD Sharing Access Criteria: Anyone
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No