Lung Diseases Clinical Trial
— C-SMART-PNOfficial title:
Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study (C SMART-PN, Pilot)
Verified date | October 2022 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | January 17, 2022 |
Est. primary completion date | October 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Minute to 2 Days |
Eligibility | Inclusion Criteria: - Infants < 28 weeks of gestational age - Obtaining parental consent before the start of the first PN prescribed by the attending physician Exclusion Criteria: - Significant congenital malformations - Infant is currently enrolled in another trial -unless approval of trial research team- - Parent inability to comprehend and consent |
Country | Name | City | State |
---|---|---|---|
Canada | CHU Sainte-Justine | Montréal | Quebec |
Canada | University of Montreal, Sainte-Justine Hospital | Montréal |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital |
Canada,
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2004 Jul 13. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Thibeault DW. The precarious antioxidant defenses of the preterm infant. Am J Perinatol. 2000;17(4):167-81. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Urinary ascorbylperoxide (AscOOH) | Urine AscOOH concentration will be determined using Mass spectrometry. | On day 7 of life | |
Secondary | 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. | On day 7 of life | |
Secondary | 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. | At 36 weeks Post-Menstrual Age | |
Secondary | 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 | On day 7 of life | |
Secondary | 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 | At 36 weeks Post-Menstrual Age | |
Secondary | 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) | At 36 weeks Post-Menstrual Age | |
Secondary | Clinical outcome - Mortality rate | Death before 36 weeks post menstrual age | At 36 weeks Post-Menstrual Age | |
Secondary | Clinical outcome - length of mechanical ventilation (invasive, non-invasive) | Total number of days on mechanical ventilation (both invasive and non invasive respiratory support) | From birth to discharge home, an average of 4 months | |
Secondary | Clinical outcome - length of supplemental oxygen (in days) | Total number of days on Nasal cannula O2 supplements | From birth to discharge home, an average of 4 months | |
Secondary | 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 | From birth to discharge home, an average of 4 months | |
Secondary | 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. | From birth to discharge home, an average of 4 months | |
Secondary | 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. | From birth to discharge home, an average of 4 months | |
Secondary | 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. | From birth to discharge home, an average of 4 months | |
Secondary | 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. | From birth to discharge home, an average of 4 months | |
Secondary | Clinical outcome - infant anthropometry: weight | Weight in grams | At 36 weeks Post-Menstrual Age | |
Secondary | Clinical outcome - infant anthropometry: length | Length in centimeters | At 36 weeks Post-Menstrual Age | |
Secondary | Clinical outcome - infant anthropometry: head circumference | Head circumference in centimeters | At 36 weeks Post-Menstrual Age | |
Secondary | Clinical outcome - length of hospital stay (in days) | Total number of days till discharge home | From birth to discharge home, an average of 4 months |
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