An interventional study of Photo-protection and Standard Care in Parenteral Nutrition, Infant, Premature, Diseases and Infant, Newborn, Disease, sponsored by St. Justine's Hospital. Completed at 2 sites in Canada. Open to participants aged 1 Minute to 2 Days. Per ClinicalTrials.gov, last updated 2022-10-31.
Sponsored by St. Justine's Hospital · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 35 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: Baseline, 48 hours post-parenteral nutrition and on day 7 of life
Urinary ascorbylperoxide (AscOOH)
Urine AscOOH concentration will be determined using Mass spectrometry.
Time frame: 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.
Time frame: 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.
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)
Multiplex assay (Luminex R\&D systems), using 0.1 ml of blood
Time frame: 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
Time frame: 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)
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - Mortality rate
Death before 36 weeks post menstrual age
Time frame: 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)
Time frame: 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
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)
Necrotizing enterocolitis stages as defind by Bell stage II or higher. The incidence in the two arms will be reported and compared
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
Any intraventricular hemorrhage (IVH), IVH grade III and IV in each arm will be reported and compared.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: From birth to discharge home, an average of 4 months
Clinical outcome - infant anthropometry: weight
Weight in grams
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - infant anthropometry: length
Length in centimeters
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - infant anthropometry: head circumference
Head circumference in centimeters
Time frame: At 36 weeks Post-Menstrual Age
Clinical outcome - length of hospital stay (in days)
Total number of days till discharge home
Time frame: From birth to discharge home, an average of 4 months
Plan to share: 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).
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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St. Justine's Hospital