Safety of Manganese Restriction in Neonatal Parenteral Nutrition

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: July 22, 2021

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.

Interventions

  • 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.”

Arms, Groups and Cohorts

  • Active Comparator: Standard neonatal trace elements
    • Parenteral nutrition containing 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.

Clinical Trial Outcome Measures

Primary Measures

  • Whole Blood Manganese
    • Time Frame: Baseline
    • concentration of manganese in blood
  • Whole Blood Manganese
    • Time Frame: 2 weeks of age
    • concentration of manganese in blood
  • Whole Blood Manganese
    • Time Frame: 8 weeks of age
    • concentration of manganese in blood

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 1 Day

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sharp HealthCare
  • Collaborator
    • Food and Drug Administration (FDA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jason Sauberan, PharmD, Clinical Research Pharmacist – Sharp HealthCare
  • Overall Official(s)
    • Jason B Sauberan, PharmD, Principal Investigator, Sharp HealthCare

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.