Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Infant, Newborn, Disease Clinical Trial

Official title:

Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259008
• Other study ID #: 2001902
• Status: Completed
• Phase: Phase 4
• Start date: June 11, 2020
• Est. completion date: July 22, 2021

Study information

• Verified date: August 2021
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn, Disease
• Infant, Newborn, Diseases

Intervention

Other:
• Manganese omission
Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.
• 5 mCg/kg/day manganese from "Multitrace-4 Neonatal."
5 mCg/kg/day manganese from "Multitrace-4 Neonatal."

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Blood Manganese	concentration of manganese in blood	Baseline
Primary	Whole Blood Manganese	concentration of manganese in blood	2 weeks of age
Primary	Whole Blood Manganese	concentration of manganese in blood	8 weeks of age