Complete Shielding of Multivitamins to Reduce Toxic Peroxides in the Parenteral Nutrition: A Pilot Study (C SMART-PN, Pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Change in urine peroxides concentration
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary outcome is the concentration of peroxides in the urine. The urine samples will not indicate the arm of the study.
入排标准
- 年龄范围
- 1 Minute 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants < 28 weeks of gestational age
- •Obtaining parental consent before the start of the first PN prescribed by the attending physician
排除标准
- •Significant congenital malformations
- •Infant is currently enrolled in another trial -unless approval of trial research team-
- •Parent inability to comprehend and consent
结局指标
主要结局
Change in urine peroxides concentration
时间窗: 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.
次要结局
- Urinary ascorbylperoxide (AscOOH)(On day 7 of life)
- 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)
- Clinical outcome - Incidence of significant Patent Ductus Arteriosus (PDA)(From birth to discharge home, an average of 4 months)
- Clinical outcome - infant anthropometry: weight(At 36 weeks Post-Menstrual Age)
- Whole blood glutathione redox potential(At 36 weeks Post-Menstrual Age)
- Clinical outcome - length of mechanical ventilation (invasive, non-invasive)(From birth to discharge home, an average of 4 months)
- Clinical outcome - length of supplemental oxygen (in days)(From birth to discharge home, an average of 4 months)
- Clinical outcome - Incidence and stage of necrotizing enterocolitis (According to Bell's classification)(From birth to discharge home, an average of 4 months)
- Clinical outcome - Incidence of Bronchopulmonary dysplasia (BPD) and BPD severity (Mild, moderate, sever)(At 36 weeks Post-Menstrual Age)
- Clinical outcome - Mortality rate(At 36 weeks Post-Menstrual Age)
- Clinical outcome - Incidence and grade of intraventricular hemorrhage (IVH), according to Papille criteria(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)(From birth to discharge home, an average of 4 months)
- Clinical outcome - infant anthropometry: length(At 36 weeks Post-Menstrual Age)
- Clinical outcome - Incidence and stage of Retinopathy Of Prematurity (ROP) (highest stage)(From birth to discharge home, an average of 4 months)
- Clinical outcome - infant anthropometry: head circumference(At 36 weeks Post-Menstrual Age)
- Clinical outcome - length of hospital stay (in days)(From birth to discharge home, an average of 4 months)
研究者
Ibrahim Mohamed
Paediatrician-Neonatologist, Associate professor of Paediatrics and Nutrition
St. Justine's Hospital