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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | photoprotected parenteral nutrition |
|
| 2 | Active Comparator | Non-photoprotected parenteral nutrition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| photoprotected bags, tubing, syringes | Device | use of photoprotected parenteral nutrition device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Death or bronchopulmonary dysplasia at 28 days | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Retinopathy of prematurity | 36 weeks | |
| sepsis | 28 days and 36 weeks | |
| intraventricular hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Laborie, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angelique Denis | Lyon | 69003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24925504 | Result | Laborie S, Denis A, Dassieu G, Bedu A, Tourneux P, Pinquier D, Kermorvant E, Millet V, Klosowski S, Patural H, Clamadieu C, Brunhes A, Walther M, Jaisson-Hot I, Mandy B, Claris O. Shielding Parenteral Nutrition Solutions From Light: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):729-37. doi: 10.1177/0148607114537523. Epub 2014 Jun 12. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D013594 | Syringes |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| standard tubing and bags |
| Device |
Use of standard (transparent) parenteral nutrition device |
|
| 7 days, 24days, 36 weeks |
| periventricular leucomalacia | 36 weeks |
| tolerance of enteral nutrition | during enteral nutrition |
| enterocolitis | 36 weeks |
| D000091642 | Urogenital Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |