Back to resultsSafety of Manganese Restriction in Neonatal Parenteral Nutrition
Primary Purpose
Infant, Newborn, Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Manganese omission
5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
Sponsored by
About this trial
This is an interventional prevention trial for Infant, Newborn, Disease focused on measuring manganese, parenteral nutrition, neonate, preterm, safety
Eligibility Criteria
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
Sites / Locations
- Sharp Mary Birch Hospital for Women and Newborns
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard neonatal trace elements
Manganese-free neonatal trace elements
Arm Description
Parenteral nutrition containing 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
Parenteral nutrition containing the same trace element doses as "Multitrace-4 Neonatal" minus manganese.
Outcomes
Primary Outcome Measures
Whole Blood Manganese
concentration of manganese in blood
Whole Blood Manganese
concentration of manganese in blood
Whole Blood Manganese
concentration of manganese in blood
Secondary Outcome Measures
Full Information
NCT ID
NCT04259008
First Posted
February 5, 2020
Last Updated
August 23, 2021
Sponsor
Sharp HealthCare
Collaborators
Food and Drug Administration (FDA)
1. Study Identification
Unique Protocol Identification Number
NCT04259008
Brief Title
Safety of Manganese Restriction in Neonatal Parenteral Nutrition
Official Title
Safety of Manganese Restriction in Neonatal Parenteral Nutrition
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
July 22, 2021 (Actual)
Study Completion Date
July 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
Collaborators
Food and Drug Administration (FDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Disease
Keywords
manganese, parenteral nutrition, neonate, preterm, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized to standard trace element dose in parenteral nutrition vs. omission of manganese.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard neonatal trace elements
Arm Type
Active Comparator
Arm Description
Parenteral nutrition containing 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
Arm Title
Manganese-free neonatal trace elements
Arm Type
Experimental
Arm Description
Parenteral nutrition containing the same trace element doses as "Multitrace-4 Neonatal" minus manganese.
Intervention Type
Other
Intervention Name(s)
Manganese omission
Intervention Description
Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.
Intervention Type
Other
Intervention Name(s)
5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
Intervention Description
5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
Primary Outcome Measure Information:
Title
Whole Blood Manganese
Description
concentration of manganese in blood
Time Frame
Baseline
Title
Whole Blood Manganese
Description
concentration of manganese in blood
Time Frame
2 weeks of age
Title
Whole Blood Manganese
Description
concentration of manganese in blood
Time Frame
8 weeks of age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason B Sauberan, PharmD
Organizational Affiliation
Sharp HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Immediately after publication
IPD Sharing Access Criteria
Anyone
Learn more about this trial
Safety of Manganese Restriction in Neonatal Parenteral Nutrition
We'll reach out to this number within 24 hrs