Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Phase 4

Completed

• Conditions: Infant, Newborn, Disease
• Interventions: Other: 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."; Other: Manganese omission

• Registration Number: NCT04259008
• Lead Sponsor: Sharp HealthCare

Brief 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.

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.

Study Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2020-06-11
• Primary Completion: 2021-07-22
• Study Completion: 2021-07-22
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard neonatal trace elements	5 mCg/kg/day manganese from "Multitrace-4 Neonatal."	Parenteral nutrition containing 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
Manganese-free neonatal trace elements	Manganese omission	Parenteral nutrition containing the same trace element doses as "Multitrace-4 Neonatal" minus manganese.

Primary Outcome Measures

Name	Time	Method
Whole Blood Manganese	8 weeks of age	concentration of manganese in blood

Trial Locations

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns; 🇺🇸 San Diego, California, United States