Perenteral Nutrition and Oxidative Stress in Preterm Infants

Study Overview
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Brief Summary
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In an effort to decrease the load of peroxides in TPN solutions, multiple studies examined different strategies such as photo-protection, adding multivitamins to the lipid emulsion rather than to the dextrose-amino acid admixture, and adding antioxidants such as glutathione to the TPN solution. However, the role of trace elements as antioxidants, and their interaction with light have not been studied. Also, the impact of TPN-related oxidants on clinical morbidities has not been addressed. Therefore, we aimed in this study of preterm infants to evaluate the role of different components of TPN on urinary peroxides and to examine the biochemical and clinical effects of light protection.

Official Title
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Study of the Oxidant-Antioxidant Effects of Parenteral Nutrition in Preterm Neonates

Conditions
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Preterm Infants

Intervention / Treatment
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* Other: Photo-protection
* Other: Photo-exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants included are: with gestational age between 28 to 34 weeks managed with TPN as part of their care in the NICU their postnatal age on enrolment was < 7 days Exclusion Criteria: Infants are excluded if they have: Clinical evidence of sepsis, or a positive blood culture on admission Hepatobiliary dysfunction Persistent metabolic acidosis with base deficit > 10 mEq / L Renal impairment (urine output < 1 ml/kg/hour and serum creatinine > 1 mg/dl) Disseminated intravascular coagulopathy Maternal conditions known to be associated with oxidative stress such as preeclampsia, hypertension and diabetes.

Ages Eligible for Study
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Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Perenteral nutrition bottle and tubing are not protected from light | Other: Photo-exposure<br>* Perenteral nutrition bottles and tubings are allowed to be exposed to day light.<br>|
| Active Comparator: 2<br>Perenteral nutrition bottle and tubing are protected from light | Other: Photo-protection<br>* Parenteral solutions are protected from day light using aluminum covers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of peroxides in the urine |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical morbidities (death, and bronchopulmonary dysplasia) |  | during hospital stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TPN, preterm, parenteral nutrition, lipid emulsions, photo-protection, oxidative stress