NCT04234152

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

January 8, 2020

Last Update Submit

October 27, 2022

Conditions

Parenteral NutritionInfant, Premature, DiseasesInfant, Newborn, DiseaseLung DiseasesRespiratory Tract DiseaseBronchopulmonary DysplasiaPathologic Processes

Keywords

Photo-protection of MultivitaminsOxidative StressAscorbyl peroxideUrine peroxides

Outcome Measures

Primary Outcomes (1)

  • Change in urine peroxides concentration

    From each urine sample, an aliquot (0.2 ml) will be used for creatinin measurement whereas another (0.5 ml) will be used for peroxide determination using the ferrous oxidation/xylenol orange technique. H2O2 will serve for the standard curve. The results will be expressed as μmol equ H2O2/mg creatinine.

    Baseline, 48 hours post-parenteral nutrition and on day 7 of life

Secondary Outcomes (18)

  • Urinary ascorbylperoxide (AscOOH)

    On day 7 of life

  • Whole blood glutathione redox potential

    On day 7 of life

  • Whole blood glutathione redox potential

    At 36 weeks Post-Menstrual Age

  • Serum inflammatory cytokines: Interleukin 1 alpha (IL-1alpha) and beta (IL-1beta), Interleukin 6 (IL-6), Interleukin 8 (IL-8), Interleukin (IL-10), Tumor Necrosis Factor alpha (TNF-alpha), Vascular Endothelial Growth Factor (VEGF)

    On day 7 of life

  • Serum inflammatory cytokines: IL-1alpha, IL-1beta, IL-6, IL-8, IL-10, TNF-alpha, VEGF

    At 36 weeks Post-Menstrual Age

  • +13 more secondary outcomes

Study Arms (2)

MV Photo-protection

EXPERIMENTAL

Includes infants in whom the new procedure of MV separation and photo-protection will be applied. This arm will be stratified to male and female 1:1

Other: Photo-protection

Standard of care

PLACEBO COMPARATOR

Includes infants in whom the standard method of preparation and infusion of PN will be applied. This arm will be stratified to male and female 1:1

Other: Standard Care

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.

MV Photo-protection
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.

Standard of care

Eligibility Criteria

Age1 Minute - 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants \< 28 weeks of gestational age
  • Obtaining parental consent before the start of the first PN prescribed by the attending physician

You may not qualify if:

  • Significant congenital malformations
  • Infant is currently enrolled in another trial -unless approval of trial research team-
  • Parent inability to comprehend and consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

University of Montreal, Sainte-Justine Hospital

Montreal, Canada

Location

Related Publications (11)

  • Thibeault DW. The precarious antioxidant defenses of the preterm infant. Am J Perinatol. 2000;17(4):167-81. doi: 10.1055/s-2000-9422.

    PMID: 11041438BACKGROUND

  • Mohamed I, Elremaly W, Rouleau T, Lavoie JC. Oxygen and parenteral nutrition two main oxidants for extremely preterm infants: 'It all adds up'. J Neonatal Perinatal Med. 2015;8(3):189-97. doi: 10.3233/NPM-15814091.

    PMID: 26485550BACKGROUND

  • Saugstad OD. Oxygen and oxidative stress in bronchopulmonary dysplasia. J Perinat Med. 2010 Nov;38(6):571-7. doi: 10.1515/jpm.2010.108. Epub 2010 Aug 31.

    PMID: 20807008BACKGROUND

  • Laborie S, Lavoie JC, Pineault M, Chessex P. Contribution of multivitamins, air, and light in the generation of peroxides in adult and neonatal parenteral nutrition solutions. Ann Pharmacother. 2000 Apr;34(4):440-5. doi: 10.1345/aph.19182.

    PMID: 10772427BACKGROUND

  • Laborie S, Lavoie JC, Chessex P. Increased urinary peroxides in newborn infants receiving parenteral nutrition exposed to light. J Pediatr. 2000 May;136(5):628-32. doi: 10.1067/mpd.2000.105131.

    PMID: 10802495BACKGROUND

  • Bassiouny MR, Almarsafawy H, Abdel-Hady H, Nasef N, Hammad TA, Aly H. A randomized controlled trial on parenteral nutrition, oxidative stress, and chronic lung diseases in preterm infants. J Pediatr Gastroenterol Nutr. 2009 Mar;48(3):363-9. doi: 10.1097/mpg.0b013e31818c8623.

    PMID: 19274793BACKGROUND

  • Mohamed I, Elremaly W, Rouleau T, Lavoie JC. Ascorbylperoxide Contaminating Parenteral Nutrition Is Associated With Bronchopulmonary Dysplasia or Death in Extremely Preterm Infants. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):1023-1029. doi: 10.1177/0148607116643704. Epub 2016 Apr 1.

    PMID: 27036126BACKGROUND

  • Elremaly W, Mohamed I, Mialet-Marty T, Rouleau T, Lavoie JC. Ascorbylperoxide from parenteral nutrition induces an increase of redox potential of glutathione and loss of alveoli in newborn guinea pig lungs. Redox Biol. 2014 May 20;2:725-31. doi: 10.1016/j.redox.2014.05.002. eCollection 2014.

    PMID: 25009773BACKGROUND

  • Lavoie JC, Rouleau T, Chessex P. Interaction between ascorbate and light-exposed riboflavin induces lung remodeling. J Pharmacol Exp Ther. 2004 Nov;311(2):634-9. doi: 10.1124/jpet.104.070755. Epub 2004 Jul 13.

    PMID: 15254143BACKGROUND

  • Chessex P, Harrison A, Khashu M, Lavoie JC. In preterm neonates, is the risk of developing bronchopulmonary dysplasia influenced by the failure to protect total parenteral nutrition from exposure to ambient light? J Pediatr. 2007 Aug;151(2):213-4. doi: 10.1016/j.jpeds.2007.04.029.

    PMID: 17643781BACKGROUND

  • Chessex P, Laborie S, Nasef N, Masse B, Lavoie JC. Shielding Parenteral Nutrition From Light Improves Survival Rate in Premature Infants. JPEN J Parenter Enteral Nutr. 2017 Mar;41(3):378-383. doi: 10.1177/0148607115606407. Epub 2016 Sep 30.

    PMID: 26376662BACKGROUND

MeSH Terms

Conditions

HyperphagiaInfant, Premature, DiseasesDiseaseLung DiseasesRespiratory Tract DiseasesBronchopulmonary DysplasiaPathologic Processes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVentilator-Induced Lung InjuryLung Injury

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ibrahim Mohamed, M.D.,Ph.D.

    Sainte-Justine Research center, Sainte-Justine hospital, University of Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The primary outcome is the concentration of peroxides in the urine. The urine samples will not indicate the arm of the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paediatrician-Neonatologist, Associate professor of Paediatrics and Nutrition

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 21, 2020

Study Start

November 23, 2020

Primary Completion

October 27, 2021

Study Completion

January 17, 2022

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

The authors will do every efforts to make the study protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR) and analytic code available to other researcher (either by protocol publication before the study of as supplemental material with the final publication).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Within 6 months of collecting all data and for a maximum of 2 years
Access Criteria
Anonymized information will be available for research and academic purposes.

Locations

CA(2)