Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Study Overview
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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.

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.

Official Title
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Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Conditions
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Infant, Newborn, Disease

Intervention / Treatment
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* Other: Manganese omission
* Other: 5 mCg/kg/day manganese from Multitrace-4 Neonatal.


Participation Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomized to standard trace element dose in parenteral nutrition vs. omission of manganese.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manganese, parenteral nutrition, neonate, preterm, safety