Consequences of Parenteral Nutrition Photoprotection on Oxidant Related Diseases Among Extremely Low Birth Weight Infants

Study Overview
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Brief Summary
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The antioxidant system of very low birth weight infants is immature. This immaturity is implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy. The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant. Photoprotection decreases the oxidant load infused with parenteral nutrition. In a preliminary study, photoprotection reduced the frequency of pulmonary bronchodysplasia, increased the quantity of enteral nutrition tolerated, and decreased the arterial blood pressure among very low birth weight infants. The aim of this study is to evaluate the impact of photoprotection on oxidant related diseases among very low birth weight infants. This study is a randomized multicenter trial. In the intervention group, photoprotection is applied until the infusion of parenteral nutrition with amber bags, tubing, and syringes. The quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24 hours of infusion. The control group will receive parenteral nutrition with transparent bags and tubing. The outcomes are evaluated at 36 weeks, and 680 infants will be enrolled, with stratification among centers and gestational age.

Official Title
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Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study

Conditions
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Infant, Premature

Intervention / Treatment
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* Device: photoprotected bags, tubing, syringes
* Device: standard tubing and bags


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born before 30 weeks gestational age Postnatal age between 1 and 6 days Apgar score up to 2 Exclusion Criteria: Severe congenital abnormalities Intraventricular hemorrhage grade up to 2 Proven sepsis before inclusion Transfusion before inclusion Use of intravenous lipids or parenteral nutrition before randomisation

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 6 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 |
| --- | --- |
| Experimental: 1<br>photoprotected parenteral nutrition | Device: photoprotected bags, tubing, syringes<br>* use of photoprotected parenteral nutrition device<br>|
| Active Comparator: 2<br>Non-photoprotected parenteral nutrition | Device: standard tubing and bags<br>* Use of standard (transparent) parenteral nutrition device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or bronchopulmonary dysplasia at 28 days |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinopathy of prematurity |  | 36 weeks | 
| sepsis |  | 28 days and 36 weeks | 
| intraventricular hemorrhage |  | 7 days, 24days, 36 weeks | 
| periventricular leucomalacia |  | 36 weeks | 
| tolerance of enteral nutrition |  | during enteral nutrition | 
| enterocolitis |  | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photoprotection,, Parenteral nutrition, Oxidant stress, Infant, Premature