CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Photo-protection +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04234152
NCT04234152N/ACompleted
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Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study (C SMART-PN, Pilot)

St. Justine's Hospital·interventional·Posted Jan 21, 2020·Updated Oct 31, 2022

In Brief

A clinical study evaluating Photo-protection and Standard Care for Parenteral Nutrition and 6 related conditions. Completed, enrolled 35 participants across 2 sites.

Detailed Summary

The purpose of this study is to examine if a new and simple method involving complete photo-protection of multivitamins only (since sampling through infusion) will result in a significant reduction of peroxide contamination of parenteral nutrition compared to standard method of parenteral nutrition preparation and infusion in extremely preterm infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParenteral Nutrition, Infant, Premature, Diseases, Infant, Newborn, Disease, Lung Diseases, Respiratory Tract Disease, Bronchopulmonary Dysplasia, Pathologic Processes
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 21, 2020
Enrollment StartNov 23, 2020
Primary CompletionOct 27, 2021
Study CompletionJan 17, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.4 years ago

Interventions

Photo-protectionother

The MV solution is delivered from producing companies in amber vials. The MV will be sampled by the pharmacy technician in a syringe that is photo-protected with a white label indicating the subject study name, protocol number and the infusion rate. The MV will be transported to the unit in the same photo-protected syringe. In the neonatal unit, this syringe will be installed in the pump and connected to photo-protected extension duration.

Standard Careother

This group will receive the standard practice of PN compounding in the pharmacy followed by infusion in standard infusion kit available in Sainte-Justine's Hospital.