Safety of Manganese Restriction in Neonatal Parenteral Nutrition

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Sharp HealthCare
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Updated on 19 February 2024
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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.

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.

Details
Condition Infant, Newborn, Disease
Age 1years or below
Treatment Manganese omission, 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
Clinical Study IdentifierNCT04259008
SponsorSharp HealthCare
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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