Safety of Manganese Restriction in Neonatal Parenteral Nutrition

NCT04259008 | Completed Phase 4 FDA Drug

• 1 other identifier: 2001902
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn, Disease

Keywords

manganese, parenteral nutrition, neonate, preterm, safety

Outcome Measures

Primary Outcomes (3)

• Whole Blood Manganese

  concentration of manganese in blood

  Baseline

• Whole Blood Manganese

  concentration of manganese in blood

  2 weeks of age

• Whole Blood Manganese

  concentration of manganese in blood

  8 weeks of age

Study Arms (2)

Standard neonatal trace elements

ACTIVE COMPARATOR

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

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

Manganese-free neonatal trace elements

EXPERIMENTAL

Parenteral nutrition containing the same trace element doses as "Multitrace-4 Neonatal" minus manganese.

Other: Manganese omission

Interventions

Manganese omission OTHER

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

Manganese-free neonatal trace elements

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

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

Standard neonatal trace elements

Eligibility Criteria

• Age: Up to 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharp HealthCare: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Disease; Hyperphagia; Premature Birth

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jason B Sauberan, PharmD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Pharmacist

Model Details: Participants randomized to standard trace element dose in parenteral nutrition vs. omission of manganese.

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 6, 2020
• Study Start: June 11, 2020
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately after publication
• Access Criteria: Anyone

Locations

US (1)