Safety of Manganese Restriction in Neonatal Parenteral Nutrition
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sharp HealthCare
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Whole Blood Manganese
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- — to 1 Day (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Whole Blood Manganese
Time Frame: 8 weeks of age
concentration of manganese in blood
Secondary Outcomes
No secondary outcomes reported
Investigators
Jason Sauberan, PharmD
Clinical Research Pharmacist
Sharp HealthCare