Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-11

Study Completion Date

2021-07-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant, Newborn, Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized to standard trace element dose in parenteral nutrition vs. omission of manganese.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard neonatal trace elements

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Manganese-free neonatal trace elements

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

Group Type EXPERIMENTAL

Manganese omission

Intervention Type OTHER

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

Interventions

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Manganese omission

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No