Infant, Newborn, Disease
Conditions
Keywords
manganese, parenteral nutrition, neonate, preterm, safety
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.
Interventions
OTHERManganese omission
Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.
OTHER5 mCg/kg/day manganese from Multitrace-4 Neonatal.
5 mCg/kg/day manganese from Multitrace-4 Neonatal.
Sponsors
Food and Drug Administration (FDA)
Sharp HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Participants randomized to standard trace element dose in parenteral nutrition vs. omission of manganese.
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole Blood Manganese | Baseline | concentration of manganese in blood |
Countries
United States
Outcome results
None listed