Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Completed · Phase 4

Conditions studied: Infant, Newborn, Disease

In brief

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.

Key facts

Study ID

NCT04259008

Run by

Sharp HealthCare

People needed

26

Starts

2020-06-11

Expected to finish

2021-07-22

Last updated by the study team

2021-08-25

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States

Full record on ClinicalTrials.gov

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