Safety of Manganese Restriction in Neonatal Parenteral Nutrition

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04259008
Study type	Interventional
Source	Sharp HealthCare
Contact
Status	Completed
Phase	Phase 4
Start date	June 11, 2020
Completion date	July 22, 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04041765` - IgM-Enriched Immunoglobulin for Neonatal Sepsis	Phase 3
Completed	`NCT04076189` - Time of Positive Pressure Ventilation in Non-vigorous Infants Born Through Meconium-stained Amniotic Fluid	N/A
Completed	`NCT05217186` - Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Completed	`NCT04034719` - Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home	N/A
Completed	`NCT05520164` - Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection	N/A
Completed	`NCT04234152` - Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study	N/A
Completed	`NCT04635150` - National Evaluation of the Close Collaboration With Parents Training	N/A
Completed	`NCT04823026` - Host RNA Profiles to Detect Infections in Young Infants
Completed	`NCT05510271` - Pain in Newborn Heel Blood Collection	N/A
Active, not recruiting	`NCT05343403` - Parental Participation on the Neonatal Ward - the neoPARTNER Study
Completed	`NCT03985501` - DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry
Enrolling by invitation	`NCT04848090` - Genome Sequencing in the Intensive Care Unit Population	N/A
Completed	`NCT04748159` - Effects of Prone Positioning on Vital Parameters in Infants With Acute Bronchiolitis	N/A
Completed	`NCT02518230` - Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants	N/A
Recruiting	`NCT05493527` - Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates	N/A
Recruiting	`NCT04519060` - Eye Shields for Infants After Dilated Exam	N/A
Completed	`NCT02878993` - Predicting Infant Extubation Using Diaphragm Surface Electromyography
Completed	`NCT04792099` - CPAP Or Nasal Cannula Oxygen for Preterm Infants: A Randomized Controlled Trial	N/A
Completed	`NCT04035291` - Effectiveness of Family Collaborative Physiotherapy Programs With High-risk Infants	N/A
Recruiting	`NCT04697251` - Infant Forced Oscillations Technique (iFOT)	N/A