Parenteral NutritionC-SMART-PNNCT04234152
Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study
A study testing Photo-protection in people with Parenteral Nutrition and Infant, Premature, Diseases, run by St. Justine's Hospital at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 minute to 2 days
- Conditions the study is for
- Parenteral Nutrition, Infant, Premature, Diseases, Infant, Newborn, Disease
- What is being tested?
- Photo-protection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Nov 2020to 17 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants < 28 weeks of gestational age
- Obtaining parental consent before the start of the first PN prescribed by the attending physician
Who cannot join
- Significant congenital malformations
- Infant is currently enrolled in another trial -unless approval of trial research team-
- Parent inability to comprehend and consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
University of Montreal, Sainte-Justine Hospital
Montreal
About this study
Official title: Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study (C SMART-PN, Pilot)
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.
Read the detailed description
Hypothesis and Objectives:
The investigators propose, in this pilot study, a new and simple method involving complete photo-protection of multivitamins (MV) only (since sampling through infusion) and they hypothesize that this method will be readily applicable and will result in a significant reduction of peroxide contamination of parenteral nutrition (PN) compared to standard care of PN preparation and infusion method.
In Vitro Results Using This Proposed Photo-Protection Method:
This method has reduced the quantity of infused peroxides (as equivalent H2O2). When adding the generated peroxides over 5 hours (5 samples: at times 0, 30 minutes, 1, 3 and 5 hours), the total peroxides were 1270± 47 micromolar (μM) without photo-protection vs. 710±16 μM with this method, leading to 45% reduction of peroxides (data presented as a poster presentation in the Pediatric academic societies meeting , 2018, Poster number 2874.625). This reduction is comparable to the previously reported in vitro data for the whole PN complete photo-protection that reported 50% reduction of peroxides.
Specific objective of this pilot study:
To examine if this new and simple method will be feasible in clinical practice and will result in a significant reduction of urinary peroxide concentration when compared to standard PN compounding and infusion technique.
Innovation:
The investigators' team's long experience in this field permitted the identification of the interaction between light and MV (specifically riboflavin) that leads to doubling the amount of peroxides contaminating the PN. The complexity of complete photo-protection encountered by the team to conduct small uni-center studies and the incapacity to introduce the complete photo-protection in daily clinical practice led the team to create this simple intervention that will address the problem at its origin in a practical way. All trials, including complete PN photo-protection, faced the complexity of keeping MV away from light while needing to prepare the PN admixture under the light of a sterile hood. Added to this was the complexity of completely covering the PN bag while compounding the admixture. Light exposure may also occur during the transportation of the PN from the hospital pharmacy to the neonatal unit (even with special attention to the bottom of the bag and the area around the tubing being well covered).
The proposed intervention will eliminate all these complex procedures by directly sampling the MV in a photo-protected syringe, transporting it in this syringe, and directly infusing the MV into the photo-protected intravenous lines through its infusion into the patient.
- Conditions
- Parenteral Nutrition, Infant, Premature, Diseases, Infant, Newborn, Disease, Lung Diseases, Respiratory Tract Disease, Bronchopulmonary Dysplasia
- Being tested
- Photo-protection, Standard Care
- Keywords
- Photo-protection of Multivitamins, Oxidative Stress, Ascorbyl peroxide, Urine peroxides
- Medical subject headings
- Hyperphagia, Infant, Premature, Diseases, Disease, Lung Diseases, Respiratory Tract Diseases, Bronchopulmonary Dysplasia, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 48 hours post-parenteral nutrition and on day 7 of life
Secondary outcomes (18)
Urinary ascorbylperoxide (AscOOH)
Urine AscOOH concentration will be determined using Mass spectrometry.
Measured: On day 7 of life
Whole blood glutathione redox potential
Whole blood levels of glutathione (GSH) and glutathione disulfide (GSSG) will be measured by capillary electrophoresis as previously described by the investigators' team, using 0.5 ml of blood. The whole blood redox potential (mV) will be calculated, using the Nernst equation.
Measured: On day 7 of life
Whole blood glutathione redox potential
Whole blood levels of glutathione (GSH) and glutathione disulfide (GSSG) will be measured by capillary electrophoresis as previously described by our team, using 0.5 ml of blood. The whole blood redox potential (mV) will be calculated, using the Nernst equation.
Measured: 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)
Multiplex assay (Luminex R\&D systems), using 0.1 ml of blood
Measured: On day 7 of life
Serum inflammatory cytokines: IL-1alpha, IL-1beta, IL-6, IL-8, IL-10, TNF-alpha, VEGF
Multiplex assay (Luminex R\&D systems), using 0.1 ml of blood
Measured: At 36 weeks Post-Menstrual Age
Clinical outcome - Incidence of Bronchopulmonary dysplasia (BPD) and BPD severity (Mild, moderate, sever)
According to the National Institute of Child Health and Human Development (NICHD) criteria (Jobe Alan H.,2001)
Measured: At 36 weeks Post-Menstrual Age
Clinical outcome - Mortality rate
Death before 36 weeks post menstrual age
Measured: At 36 weeks Post-Menstrual Age
Clinical outcome - length of mechanical ventilation (invasive, non-invasive)
Total number of days on mechanical ventilation (both invasive and non invasive respiratory support)
Measured: From birth to discharge home, an average of 4 months
Clinical outcome - length of supplemental oxygen (in days)
Total number of days on Nasal cannula O2 supplements
Measured: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence and stage of necrotizing enterocolitis (According to Bell's classification)
Necrotizing enterocolitis stages as defind by Bell stage II or higher. The incidence in the two arms will be reported and compared
Measured: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence and grade of intraventricular hemorrhage (IVH), according to Papille criteria
Any intraventricular hemorrhage (IVH), IVH grade III and IV in each arm will be reported and compared.
Measured: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence of significant liver cholestasis (defined as two or more consecutive conjugated bilirubin values ≥ 34 μmol/L)
Cholestasis is defined as two or more consecutive conjugated bilirubin values ≥ 34 μmol/L. The incidence of cholestasis in each arm will be reported and compared.
Measured: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence and stage of Retinopathy Of Prematurity (ROP) (highest stage)
The incidence of ROP stage II and higher as defined by the National Eye Institute will be reported and compared.
Measured: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence of significant Patent Ductus Arteriosus (PDA)
PDA requiring medical or surgical treatment according to the treating neonatologist will be reported and compared.
Measured: From birth to discharge home, an average of 4 months
Clinical outcome - infant anthropometry: weight
Weight in grams
Measured: At 36 weeks Post-Menstrual Age
Clinical outcome - infant anthropometry: length
Length in centimeters
Measured: At 36 weeks Post-Menstrual Age
Clinical outcome - infant anthropometry: head circumference
Head circumference in centimeters
Measured: At 36 weeks Post-Menstrual Age
Clinical outcome - length of hospital stay (in days)
Total number of days till discharge home
Measured: From birth to discharge home, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start23 Nov 2020
- Primary completion27 Oct 2021
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mohamed, St. Justine's Hospital
- Investigators
- Ibrahim Mohamed, M.D.,Ph.D., Principal investigator, Sainte-Justine Research center, Sainte-Justine hospital, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234152
- Sponsor's protocol ID
- 2020-2713
- Acronym
- C-SMART-PN
- Status last verified
- Oct 2022
- First submitted
- 8 Jan 2020
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Thibeault DW. The precarious antioxidant defenses of the preterm infant. Am J Perinatol. 2000;17(4):167-81. doi: 10.1055/s-2000-9422.
PubMed 11041438Mohamed 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.
PubMed 26485550Saugstad 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.
PubMed 20807008Laborie 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.
PubMed 10772427Laborie 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.
PubMed 10802495Bassiouny 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.
PubMed 19274793Mohamed 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.
PubMed 27036126Elremaly 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.
PubMed 25009773Lavoie 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.
PubMed 15254143Chessex 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.
PubMed 17643781Chessex 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.
PubMed 26376662
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study (C SMART-PN, Pilot)
- ClinicalTrials.gov ID
- NCT04234152
- Acronym / sponsor ID
- C-SMART-PN / 2020-2713
- Conditions
- Parenteral Nutrition, Infant, Premature, Diseases, Infant, Newborn, Disease, Lung Diseases, Respiratory Tract Disease, Bronchopulmonary Dysplasia
- Keywords
- Photo-protection of Multivitamins, Oxidative Stress, Ascorbyl peroxide, Urine peroxides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis and Objectives:
The investigators propose, in this pilot study, a new and simple method involving complete photo-protection of multivitamins (MV) only (since sampling through infusion) and they hypothesize that this method will be readily applicable and will result in a significant reduction of peroxide contamination of parenteral nutrition (PN) compared to standard care of PN preparation and infusion method.
In Vitro Results Using This Proposed Photo-Protection Method:
This method has reduced the quantity of infused peroxides (as equivalent H2O2). When adding the generated peroxides over 5 hours (5 samples: at times 0, 30 minutes, 1, 3 and 5 hours), the total peroxides were 1270± 47 micromolar (μM) without photo-protection vs. 710±16 μM with this method, leading to 45% reduction of peroxides (data presented as a poster presentation in the Pediatric academic societies meeting , 2018, Poster number 2874.625). This reduction is comparable to the previously reported in vitro data for the whole PN complete photo-protection that reported 50% reduction of peroxides.
Specific objective of this pilot study:
To examine if this new and simple method will be feasible in clinical practice and will result in a significant reduction of urinary peroxide concentration when compared to standard PN compounding and infusion technique.
Innovation:
The investigators' team's long experience in this field permitted the identification of the interaction between light and MV (specifically riboflavin) that leads to doubling the amount of peroxides contaminating the PN. The complexity of complete photo-protection encountered by the team to conduct small uni-center studies and the incapacity to introduce the complete photo-protection in daily clinical practice led the team to create this simple intervention that will address the problem at its origin in a practical way. All trials, including complete PN photo-protection, faced the complexity of keeping MV away from light while needing to prepare the PN admixture under the light of a sterile hood. Added to this was the complexity of completely covering the PN bag while compounding the admixture. Light exposure may also occur during the transportation of the PN from the hospital pharmacy to the neonatal unit (even with special attention to the bottom of the bag and the area around the tubing being well covered).
The proposed intervention will eliminate all these complex procedures by directly sampling the MV in a photo-protected syringe, transporting it in this syringe, and directly infusing the MV into the photo-protected intravenous lines through its infusion into the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MV Photo-protection | Experimental | Other: Photo-protectionIncludes 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 |
| Standard of care | Placebo comparator | Other: Standard CareIncludes 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 |
Who may qualify
- Ages
- 1 minute to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants < 28 weeks of gestational age
- Obtaining parental consent before the start of the first PN prescribed by the attending physician
Key exclusion criteria (3 listed)
- Significant congenital malformations
- Infant is currently enrolled in another trial -unless approval of trial research team-
- Parent inability to comprehend and consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photo-protectionThe 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. | Other | MV Photo-protection |
| Standard CareThis 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. | Other | Standard of care |
Primary outcome
Change in urine peroxides concentration
Time frame: Baseline, 48 hours post-parenteral nutrition and on day 7 of life
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.
18 secondary outcomes
Urinary ascorbylperoxide (AscOOH)
Time frame: On day 7 of life
Whole blood glutathione redox potential
Time frame: On day 7 of life
Whole blood glutathione redox potential
Time frame: 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)
Time frame: On day 7 of life
Serum inflammatory cytokines: IL-1alpha, IL-1beta, IL-6, IL-8, IL-10, TNF-alpha, VEGF
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - Incidence of Bronchopulmonary dysplasia (BPD) and BPD severity (Mild, moderate, sever)
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - Mortality rate
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - length of mechanical ventilation (invasive, non-invasive)
Time frame: From birth to discharge home, an average of 4 months
Clinical outcome - length of supplemental oxygen (in days)
Time frame: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence and stage of necrotizing enterocolitis (According to Bell's classification)
Time frame: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence and grade of intraventricular hemorrhage (IVH), according to Papille criteria
Time frame: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence of significant liver cholestasis (defined as two or more consecutive conjugated bilirubin values ≥ 34 μmol/L)
Time frame: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence and stage of Retinopathy Of Prematurity (ROP) (highest stage)
Time frame: From birth to discharge home, an average of 4 months
Clinical outcome - Incidence of significant Patent Ductus Arteriosus (PDA)
Time frame: From birth to discharge home, an average of 4 months
Clinical outcome - infant anthropometry: weight
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - infant anthropometry: length
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - infant anthropometry: head circumference
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - length of hospital stay (in days)
Time frame: From birth to discharge home, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Background: PubMed 11041438Thibeault DW. The precarious antioxidant defenses of the preterm infant. Am J Perinatol. 2000;17(4):167-81. doi: 10.1055/s-2000-9422.
- Background: PubMed 26485550Mohamed 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.
- Background: PubMed 20807008Saugstad 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.
- Background: PubMed 10772427Laborie 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.
- Background: PubMed 10802495Laborie 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.
- Background: PubMed 19274793Bassiouny 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.
- Background: PubMed 27036126Mohamed 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.
- Background: PubMed 25009773Elremaly 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.
- Background: PubMed 15254143Lavoie 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.
- Background: PubMed 17643781Chessex 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.
- Background: PubMed 26376662Chessex 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibrahim Mohamed, M.D.,Ph.D. principal investigator
Sainte-Justine Research center, Sainte-Justine hospital, University of Montreal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photo-protection in people with Parenteral Nutrition and Infant, Premature, Diseases, run by St. Justine's Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine peroxides concentration (time frame: Baseline, 48 hours post-parenteral nutrition and on day 7 of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234152, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.