Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Sharp HealthCare

Status and phase: Completed; Phase 4

Conditions: Infant, Newborn, Disease

Treatments: Other: 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."; Other: Manganese omission

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04259008

2001902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Standard neonatal trace elements

Active Comparator group

Description:

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

Treatment:

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

Manganese-free neonatal trace elements

Experimental group

Description:

Parenteral nutrition containing the same trace element doses as "Multitrace-4 Neonatal" minus manganese.

Treatment:

Other: Manganese omission