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Safety of Manganese Restriction in Neonatal Parenteral Nutrition

NCT04259008 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-08-25

No results posted yet for this study

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.

Conditions

  • Infant, Newborn, Disease

Interventions

OTHER

Manganese omission

Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.

OTHER

5 mCg/kg/day manganese from "Multitrace-4 Neonatal."

5 mCg/kg/day manganese from "Multitrace-4 Neonatal."

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • Jason B Sauberan, PharmD · Sharp HealthCare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-11
Primary Completion
2021-07-22
Completion
2021-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04259008 on ClinicalTrials.gov