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NCT04259008 · ClinicalTrials.gov registry record · Phase 4

Safety of Manganese Restriction in Neonatal Parenteral Nutrition

A Phase 4 study, sponsored by Sharp HealthCare.

Completed
Registry status
Phase 4
Development phase
26
Enrollment target

NCT04259008: Completed Phase 4 study, sponsored by Sharp HealthCare.

NCT04259008 is a Phase 4 study that has completed, run by Sharp HealthCare. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04259008, a Phase 4 study, has completed, sponsored by Sharp HealthCare.

COMPLETED
Registry status
Phase 4
Development phase
26 participants
Enrollment target

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.

Primary Outcome

concentration of manganese in blood

Interventions

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

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2020-06-11
Est. Completion 2021-07-22
Phase Phase 4
Sharp HealthCare

32 total trials

What the finished NCT04259008 record still lists

NCT04259008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Manganese omission is the first listed.

NCT04259008 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04259008 about?

NCT04259008 is a clinical study titled "Safety of Manganese Restriction in Neonatal Parenteral Nutrition". 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.

What is the current status of trial NCT04259008?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2020-06-11. Estimated completion is 2021-07-22.

What interventions are being tested in trial NCT04259008?

The interventions under investigation include: Manganese omission (OTHER), 5 mCg/kg/day manganese from "Multitrace-4 Neonatal." (OTHER).

Who is sponsoring clinical trial NCT04259008?

This trial is sponsored by Sharp HealthCare, which has 32 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04259008's enrollment target sits among peer trials

26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04259008, the US trial registry maintained by the National Library of Medicine. NCT04259008 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.